Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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
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
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
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