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RamSoft PowerServer RIS/PACS 6
Ramsoft Inc
6.0.5.5100
In Commercial Distribution
- B359PSRISPACS6PRU510 ()
- Radiological PACS software
- Radiology picture archiving and communication system workstation
- Radiology information system application software
- Radiology information system
RamSoft PowerServer RIS/PACS 6
Ramsoft Inc
6.0.11.11031
In Commercial Distribution
- B359PSRISPACS6PRU110 ()
- Radiological PACS software
- Radiology picture archiving and communication system workstation
- Radiology information system application software
- Radiology information system
PS RISPACS
Ramsoft Inc
6.0.11.11031A
In Commercial Distribution
- B359PSRISPACS0 ()
PSRISPACS6
- Radiological PACS software
- Radiology information system
- Radiology information system application software
- Radiology picture archiving and communication system workstation
RamSoft PACS is a stand-alone software package that is used on general purpose computing hardware. As long as
minimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware
platform.
The software allows digital image processing, measurement, communication. and storage.
RamSoft PACS is tested according to the specifications that are documented in a RamSoft PACS System Test Plan.
Testing is an integral part of RamSoft's software development process.
The software does not contact the patient, nor does it control any life-sustaining devices. A physician has ample
opportunity for competent human intervention while interpreting images and clinical information.
Ramsoft Inc
6.0.11.11031B
In Commercial Distribution
- B359PSPACS6PRU11B0 ()
PSPACS6PRU11B
- Radiology information system
- Radiology information system application software
- Radiology picture archiving and communication system workstation
- Radiological PACS software
PowerServer is a scalable storage and distribution system for clinical images and data. Images can be stored in lossless or lossy formats. The system is DICOM compliant for image storage, archiving, retrieval, and transmission, and communicates with other DICOM devices. The system also communicates with PowerReader workstations and PowerCache servers. Acquired image data is preserved as captured and changes to display definitions are saved as presentation states so that images may always be reverted back to their initial state. PowerCache is a caching server that communicates with PowerServer and serves PowerReader workstations. A single PowerCache can serve multiple PowerReader workstations, reducing network traffic between PowerReader workstations and PowerServer.
PowerReader is a workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data stored on PowerServer and PowerCache. PowerReader can connect directly to PowerServer and can also connect via PowerCache. PowerReader provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data.
Gateway is a stand-alone DICOM compliant workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data. Gateway provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data
Ramsoft Inc
6.0.11.11031A
In Commercial Distribution
- B359PSPACS0 ()
PSPACS6
- Radiology information system
- Radiology information system application software
- Radiology picture archiving and communication system workstation
- Radiological PACS software
RamSoft PowerServer RISPACS 6
Ramsoft Inc
6.0.6.6015
In Commercial Distribution
- B359PSRISPACS6PRU60 ()
- Radiological PACS software
- Radiology picture archiving and communication system workstation
- Radiology information system application software
- Radiology information system
A dedicated computerized radiology information system (RIS) designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and generation of work lists for specific radiological systems, and in conjunction with a picture archiving and communication system (PACS). The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).
Ramsoft Inc
6.0.11.11031B
In Commercial Distribution
- B359PSRISPACS6PRU11B0 ()
PSRISPACS6PRU11B
- Radiological PACS software
- Radiology information system
- Radiology information system application software
- Radiology picture archiving and communication system workstation
RamSoft PowerServer RIS/PACS 6
Ramsoft Inc
6.0.10.10100
In Commercial Distribution
- B359PSRISPACS6PRU100 ()
- Radiological PACS software
- Radiology picture archiving and communication system workstation
- Radiology information system application software
- Radiology information system
RamSoft PowerServer RIS/PACS 6
Ramsoft Inc
6.0.5.5040
In Commercial Distribution
- B359PSRISPACS60 ()
PSRISPACS6
- Radiological PACS software
- Radiology picture archiving and communication system workstation
- Radiology information system application software
- Radiology information system
Includes 2 TekDAQ 200 Wi-Fi Wearable Sensor Acquisition Units, FootVIEW 10.0 In-Shoe Pressure Measurement Software, 2 Velcro Ankle Bands, 20 In-Shoe Sensors (model 3010-125), 2 Li-Ion Battery Packs, 2 Battery Chargers, 2 USB-C to USB-A cables, Wireless Router, Quick Start Guide, System Carrying Case and 1 On-line Training Session (USA Only)
Tekscan, Inc.
F-Scan GO System
In Commercial Distribution
- B970FG20 ()
FG2
- Body-surface pressure mapping system
Includes 2 TekDAQ 200 Wi-Fi Wearable Sensor Acquisition Units, FootVIEW 10.0 Pro In-Shoe Pressure Measurement Software, 2 Velcro Ankle Bands, 20 In-Shoe Sensors (model 3010-125), 4 Li-Po Battery Packs, 2 Battery Chargers, 2 USB-C to USB-A cables, Wireless Router, Quick Start Guide, System Carrying Case and 1 On-line Training Session (USA Only)
Tekscan, Inc.
F-Scan GO System with FootVIEW Pro
In Commercial Distribution
- B970FG2PRO0 ()
FG2PRO
- Body-surface pressure mapping system
DataLINK (DLK900) is an on-line general purpose subject worn programmable Data Acquisition System allowing the user to collect both analog and digital data from a wide range of wired sensors including Biometrics' Goniometers, Torsiometers, active EMG sensors, Accelerometers, Pinchmeters, Hand Dynamometers and Contact Switches.
This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
DLK900
In Commercial Distribution
- 05060481691925 ()
DataLINK DLK900 - plastic connectors
- Biomechanical function analysis system, motion-tracking
DataLINK (DLK900) is an on-line general purpose subject worn programmable Data Acquisition System allowing the user to collect both analog and digital data from a wide range of wired sensors including Biometrics' Goniometers, Torsiometers, active EMG sensors, Accelerometers, Pinchmeters, Hand Dynamometers and Contact Switches.
This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13.
BIOMETRICS LIMITED
DLK900
In Commercial Distribution
- 05060481692052 ()
DataLINK DLK900 - metal connectors
- Biomechanical function analysis system, motion-tracking
Canvas Dx is a prescription diagnostic aid to healthcare professionals (HCP) considering the diagnosis of Autism Spectrum Disorder (ASD) in patients 18 months through 72 months of age at risk for developmental delay. The patient’s caregiver uses a smartphone application (“App”) to fill out a caregiver questionnaire and to make video recordings of behavior at home, and then the physician fills out a medical questionnaire online. The results are made available to the physician.
Cognoa, Inc.
1.3.0
In Commercial Distribution
- 00860007260605 ()
- Neurodevelopmental disorder interpretive software
The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.
NEMARIS, INC
2.X
In Commercial Distribution
- 00859699006059 ()
- Patient health record information system
- Radiological PACS software
The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.
NEMARIS, INC
2.2.9.X
In Commercial Distribution
- 00859699006042 ()
- Radiological PACS software
- Patient health record information system
QuantorView is an image viewing software dedicated DICOM images produced by imaging equipment (CR, DR, CT, MRI, Ultrasound and etc). QuantorView is a high quality viewing software responsible for displaying PACS image data. It enables physicians to provide medical services by accessing image data and patient information from remote locations. It also enables the images to be stored to the local database of your personal computer allowing database management to operate efficiently. Physicians can utilize the software tools for researching, teaching, teleconferencing and online collaboration.
Digiray Corp.
1.2.1.466
In Commercial Distribution
- 08809466041112 ()
- Radiological PACS software
The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remote
viewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.
MOBILEODT LTD
EVA 3 Plus/EVA 3.1
In Commercial Distribution
- 17290016976547 ()
- 17290016976028 ()
- 17290016976523 ()
- 17290016976516 ()
- 17290016976509 ()
- Colposcope
The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remote
viewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.
MOBILEODT LTD
3.0
In Commercial Distribution
- 17290016976011 ()
- Colposcope
The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remote
viewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.
MOBILEODT LTD
2
In Commercial Distribution
- 17290016976004 ()
- Colposcope
LifeTrak 2012 is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following: • Dynamic donor eligibility status • Register, track, and audit donations and deferrals • On-line health history, physical findings, and collection process • Inter-active donor questionnaire (staff and/or donor/remote donor) • HLA/RBC search and match • Donor schedules • Component production and modification • Testing • Labeling • Imported Blood Processing • Inventory Management • Distribution • Material Check-In • Offline Data Entry (Re-entry if downtime) • Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2012
In Commercial Distribution
- B105LIFETRAK0 ()
- Blood bank information system application software
Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following:
• Dynamic donor eligibility status
• Register, track, and audit donations and deferrals
• On-line health history, physical findings, and collection process
• Inter-active donor questionnaire (staff and/or donor/remote donor)
• HLA/RBC search and match
• Donor schedules
• Component production and modification
• Testing
• Labeling
• Imported Blood Processing
• Inventory Management
• Distribution
• Material Check-In
• Offline Data Entry (Re-entry if downtime)
• Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2023
In Commercial Distribution
- B105BLOODCENTERS2023 ()
- Blood bank information system application software
Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following:
• Dynamic donor eligibility status
• Register, track, and audit donations and deferrals
• On-line health history, physical findings, and collection process
• Inter-active donor questionnaire (staff and/or donor/remote donor)
• HLA/RBC search and match
• Donor schedules
• Component production and modification
• Testing
• Labeling
• Imported Blood Processing
• Inventory Management
• Distribution
• Material Check-In
• Offline Data Entry (Re-entry if downtime)
• Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2019
In Commercial Distribution
- B105BLOODCENTERS2019 ()
- Blood bank information system application software
Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following: • Dynamic donor eligibility status • Register, track, and audit donations and deferrals • On-line health history, physical findings, and collection process • Inter-active donor questionnaire (staff and/or donor/remote donor) • HLA/RBC search and match • Donor schedules • Component production and modification • Testing • Labeling • Imported Blood Processing • Inventory Management • Distribution • Material Check-In • Offline Data Entry (Re-entry if downtime) • Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2018
In Commercial Distribution
- B105BLOODCENTERS2018 ()
- Blood bank information system application software
Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following:
• Dynamic donor eligibility status
• Register, track, and audit donations and deferrals
• On-line health history, physical findings, and collection process
• Inter-active donor questionnaire (staff and/or donor/remote donor)
• HLA/RBC search and match
• Donor schedules
• Component production and modification
• Testing
• Labeling
• Imported Blood Processing
• Inventory Management
• Distribution
• Material Check-In
• Offline Data Entry (Re-entry if downtime)
• Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2022
In Commercial Distribution
- B105BLOODCENTERS0 ()
- Blood bank information system application software
Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following: • Dynamic donor eligibility status • Register, track, and audit donations and deferrals • On-line health history, physical findings, and collection process • Inter-active donor questionnaire (staff and/or donor/remote donor) • HLA/RBC search and match Donor schedules • Component production and modification • Testing • Labeling • Imported Blood Processing • Inventory Management • Distribution • Material Check-In • Offline Data Entry (Re-entry if downtime) • Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2024
In Commercial Distribution
- B10520241 ()
- Blood bank information system application software
The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit is a direct to consumer product for testing of anterior nasal swab specimens collected at home using the LetsGetChecked Coronavirus (COVID-19) Home Collection Kit by any individuals, age 18 years and older (self-collected), 12 years and older (self-collected under adult supervision), or 2 years and older (collected with adult assistance) including individuals without symptoms or other reasons to suspect COVID-19. The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit enables the at-home collection of an anterior nasal swab sample that is then transported to a laboratory designated by LetsGetChecked, Inc. for TMA testing for SARS-CoV-2 with the LetsGetChecked Coronavirus (COVID-19) Test without prescription. The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit may be available direct to consumer (DTC) without a prescription at a physical retail location and online direct to consumer. Activation can only be completed by an adult. When a minor is using the kit, it is activated in a sub-account of the adult. Customers cannot create a sub-account for an infant (<2years). LetsGetChecked HCP will contact all individuals receiving positive and invalid test results. Individuals with negative test results will be notified by email, phone message and through the website portal. For purposes of this EUA, a healthcare provider includes any healthcare professional with prescribing abilities including, but not limited to, physicians, nurses, pharmacists, and laboratory directors. The healthcare provider contacting individuals with test results will have prescribing privileges for that individual, should medication be indicated for treatment.
PRIVAPATH DIAGNOSTICS LIMITED
NO14S, NO15S, NO05S
In Commercial Distribution
- 00860002028095 ()
- Oral/upper respiratory tract specimen collection kit IVD, home-use
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
5015-300
In Commercial Distribution
- 00848665036664 ()
- Surgical screwdriver, single-use
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0463-300
In Commercial Distribution
- 00848665035155 ()
- Surgical screwdriver, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0448-200
In Commercial Distribution
- 00848665034349 ()
- Surgical screwdriver, single-use, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0431-100
In Commercial Distribution
- 00848665034158 ()
- Surgical instrument handle, non-torque-limiting
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0463-200
In Commercial Distribution
- 00848665034080 ()
- Surgical screwdriver, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0432-300
In Commercial Distribution
- 00848665033113 ()
0432-300
- Surgical screwdriver, single-use, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0452-100
In Commercial Distribution
- 00848665033069 ()
0452-100
- Surgical screwdriver, single-use, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0448-100
In Commercial Distribution
- 00848665033052 ()
- Surgical screwdriver, single-use, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
5025-200
In Commercial Distribution
- 00848665033007 ()
- Surgical screwdriver, single-use, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
5025-300
In Commercial Distribution
- 00848665032178 ()
- Surgical screwdriver, single-use, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
5031-000
In Commercial Distribution
- 00848665031522 ()
- Surgical screwdriver, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
5008-100
In Commercial Distribution
- 00848665030051 ()
- Surgical screwdriver, single-use, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
5027
In Commercial Distribution
- 00848665029239 ()
- Surgical screwdriver, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
5026
In Commercial Distribution
- 00848665029222 ()
- Surgical screwdriver, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
5025
In Commercial Distribution
- 00848665028041 ()
- Surgical screwdriver, single-use, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0458-100
In Commercial Distribution
- 00848665027778 ()
- Surgical screwdriver, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
5015
In Commercial Distribution
- 00848665027563 ()
- Surgical screwdriver, single-use, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
5014-000
In Commercial Distribution
- 00848665027556 ()
5014-000
- Surgical screwdriver, single-use, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
5024
In Commercial Distribution
- 00848665027471 ()
- Surgical screwdriver, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
5022
In Commercial Distribution
- 00848665027464 ()
- Surgical screwdriver, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
5017
In Commercial Distribution
- 00848665027457 ()
- Surgical screwdriver, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
5023
In Commercial Distribution
- 00848665027303 ()
- Surgical screwdriver, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
5018
In Commercial Distribution
- 00848665024067 ()
- Surgical screwdriver, reusable