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PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVA01
In Commercial Distribution
- 00195278330413 ()
5863721
- Wireless patient monitor/sensor reporting software, professional-only
PULSE Software Package including IOM, iG
Nuvasive, Inc.
8000104
In Commercial Distribution
- 00195377099013 ()
- Orthopaedic stereotactic surgery system
PGDx elio™ tissue complete software
PERSONAL GENOME DIAGNOSTICS INC.
B01103200
In Commercial Distribution
- 00192721000770 ()
B01103200
- Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
PillCam™ Web Software v9, USA
Given Imaging, Inc.
FGS-0639
In Commercial Distribution
- 07290110360214 ()
- Video capsule endoscopy system application software
Site~Rite 8 Software v. 3.0.1
Bard Access Systems, Inc.
SR8v3.0.1
In Commercial Distribution
- 00801741225895 ()
SR8v3.0.1
- General-purpose ultrasound imaging system
Site~Rite 8 Sherlock Application Software
Bard Access Systems, Inc.
Sherlockv3.1.1
In Commercial Distribution
- 00801741219436 ()
Sherlockv3.1.1
- Central venous catheter navigation system, electrocardiographic/magnetic
Site~Rite 8 Software v. 2.3.1
Bard Access Systems, Inc.
SR8v2.3.1
In Commercial Distribution
- 00801741219382 ()
SR8v2.3.1
- General-purpose ultrasound imaging system
Site~Rite 8 Host System Software
Bard Access Systems, Inc.
SR8v2.2.0
In Commercial Distribution
- 00801741219344 ()
SR8v2.2.0
- General-purpose ultrasound imaging system
Site~Rite 8 Ultrasound Application Software
Bard Access Systems, Inc.
SR8 USv2.2.0
In Commercial Distribution
- 00801741219252 ()
SR8 USv2.2.0
- General-purpose ultrasound imaging system
Sherlock 3CG+ TCS Software Version 3.1.0
Bard Access Systems, Inc.
Sherlock 3CG+ TCS Software Version 3.1.0
In Commercial Distribution
- 00801741188718 ()
Sherlock 3CG+ TCS Software Version 3.1.0
- Central venous catheter navigation system, electrocardiographic/magnetic
Site~Rite 8 Ultrasound System Software
Bard Access Systems, Inc.
SR8v1.0.3
In Commercial Distribution
- 00801741121449 ()
SR8v1.0.3
- General-purpose ultrasound imaging system
Cardiostation Software sold with wireless devices.
UNIVERSAL MEDICAL, INC.
Cardiostation Standalone Software
In Commercial Distribution
- B147CSS0 ()
- Electrocardiography telemetric monitoring system
Cardiostation Software sold with TTM module.
UNIVERSAL MEDICAL, INC.
Cardiostation® Advantage Software
In Commercial Distribution
- B147CA0 ()
- Electrocardiography telemetric monitoring system
Phadia Information Data Manager Software Package
Phadia AB
12-3801-11
In Commercial Distribution
- 07333066001012 ()
12-3801-11
- Laboratory instrument/analyser application software IVD
SOFTWARE MMT-8061 INS PEN ANDROID APP
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution
- 00763000489960 ()
- Empty self-injector, mechanical
SOFTWARE MMT-8060 INSULIN PEN IOS APP
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution
- 00763000489953 ()
- Empty self-injector, mechanical
POSTOPERATIVE TLHEX MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.0
In Commercial Distribution
- 18052469476444 ()
TLHEXMODULESW
- Radiological PACS software
SOFTWARE APP A610 DBS CLINICIAN V5.0
MEDTRONIC, INC.
A610
In Commercial Distribution
- 00763000975029 ()
- Multiple active implantable device programmer
Software upgrade for Coroventis CoroFlow System
COROVENTIS Research AB
12000-20
In Commercial Distribution
- 07350111070663 ()
- Cardiac catheterization laboratory computer
Software Version 1.3 for Aurora Xi
Fresenius Kabi AG
1.3
In Commercial Distribution
- 00810020440898 ()
- Apheresis system
Aurora Plasmapheresis System Software Version 2.1
Fresenius Kabi AG
SW 2.1
In Commercial Distribution
- 00810020440003 ()
- 10810020440000 ()
- Apheresis system
TIP, PROFUSION, MACH XL WITH SOFTWARE
SOLTA MEDICAL
40-01746
In Commercial Distribution
- 00816995020615 ()
40-01746
- Multi-modality skin surface treatment system
Cytomics FC 500 with CXP Software
Beckman Coulter, Inc.
UPS (CXP)
In Commercial Distribution
- 15099590572839 ()
626553
- Flow cytometry analyser IVD, semi-automated
WEREWOLF MAIN SOFTWARE UPGRADE V. 2.5-1.4
Smith & Nephew, Inc.
72290133
In Commercial Distribution
- 00885556692516 ()
72290133
- Electrosurgical system generator
Software version is in Application Identifier (8012)
Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
WPUSB01
Not in Commercial Distribution
- 00850013007110 ()
WPUSB01
- Hearing aid/implant system programming interface unit
VITEK ® 2 software 8.01 update, advanced software to run your VITEK ® 2 system
BIOMERIEUX , INC.
8.01
In Commercial Distribution
- 03573026553968 ()
- Microorganism identification/antimicrobial-susceptibility analyser IVD
360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigation. The software contains two modules, 360CAS Knee and 360CAS Hip.
KICO KNEE INNOVATION COMPANY PTY LIMITED
2.1.0
In Commercial Distribution
- B432360CAS2100 ()
- Robotic surgical navigation system application software
encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.12
In Commercial Distribution
- 09120109830122 ()
- Bioelectrical signal analysis software
encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.6
In Commercial Distribution
- 09120109830078 ()
- Bioelectrical signal analysis software
NeuroMatch is a Software as Medical Device intended for physicians to review EEG data.
LVIS CORPORATION
1.0.4
In Commercial Distribution
- 00850056774000 ()
- Bioelectrical signal analysis software
Persyst 15 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P15
In Commercial Distribution
- 00869732000166 ()
- Bioelectrical signal analysis software
This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Persyst Development Corp
App for Web
Not in Commercial Distribution
- 00869732000142 ()
- Bioelectrical signal analysis software
The Persyst Mobile App is a software application that can be executed on a mobile platform. It is capable of displaying the original EEG data, and quantitative analysis of EEG data generated by the Persyst EEG Review and Analysis Software. This Mobile App is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information.
Persyst Development Corp
Persyst Mobile App
In Commercial Distribution
- 00869732000135 ()
- Bioelectrical signal analysis software
Persyst 14 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P14
In Commercial Distribution
- 00869732000128 ()
- Bioelectrical signal analysis software
Persyst 13 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P13
In Commercial Distribution
- 00869732000111 ()
- Bioelectrical signal analysis software
Persyst 12 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P12
In Commercial Distribution
- 00869732000104 ()
- Bioelectrical signal analysis software
Koios Decision Support (DS) is a software application designed to assist trained interpreting physicians in analyzing breast and thyroid ultrasound images. The software device is a web application that is deployed to a Microsoft IIS web server and accessed by a user through a compatible client. Once logged in and granted access to the Koios DS application, the user examines selected breast or thyroid ultrasound DICOM images. The user selects Regions of Interest (ROIs) of orthogonal views of a breast lesion or thyroid nodule for processing by Koios DS. The ROI(s) are transmitted electronically to the Koios DS server for image processing and the results are returned to the user for review.
KOIOS MEDICAL, INC.
3.x
In Commercial Distribution
- 00860002545714 ()
- Ultrasound imaging system application software
No Description
GE Healthcare Finland Oy
E-ENTROPY-01
In Commercial Distribution
- 00840682104272 ()
- Patient monitoring system module, electroencephalographic
IP Alarm Relay Box accessory kit
XLTEK
024006
In Commercial Distribution
- 00382830058575 ()
- Electroencephalograph
Patient Room Alarm Relay Box (IP Version)
XLTEK
023019
In Commercial Distribution
- 00382830058216 ()
- Electroencephalograph
IP Alarm Controller, Box
XLTEK
022979
In Commercial Distribution
- 00382830058209 ()
- Electroencephalograph
Multi-exercise respiratory therapy device with OmniFlow software and sensor, and Synchrony software, electrodes, and sensing devices
ACCELERATED CARE PLUS CORP
100MTS
In Commercial Distribution
- 00858703006320 ()
- Bioelectrical signal analysis software
- Biomechanical function analysis/interactive rehabilitation system
- Monitoring spirometer, mechanical
Software, Version 1.0.0.1, Treatment Delivery Console (TDC), Radixact
(Operating Software for Radixact® Treatment Delivery System)
ACCURAY INCORPORATED
1050241
In Commercial Distribution
- M65810502410 ()
NA
- Linear accelerator system
Software, Version 1.0.0.3, Treatment Delivery Console (TDC), Radixact
(Operating Software for Radixact® Treatment Delivery System)
ACCURAY INCORPORATED
1056593
In Commercial Distribution
- M65810565930 ()
NA
- Linear accelerator system
Software, Version 1.0.0.2, Treatment Delivery Console, Radixact
Version 1.0.0.2
(Operating Software for Radixact Treatment Delivery System)
ACCURAY INCORPORATED
1055487
In Commercial Distribution
- M65810554870 ()
NA
- Linear accelerator system
No Description
EPIC SYSTEMS CORPORATION
1
In Commercial Distribution
- 00860475000383 ()
- Wound management image-analysis software
Widex BEYOND B-F2 (Silver white ) Telecoil, RC coil
Widex A/S
B-F2
In Commercial Distribution
- 05706069659788 ()
8 393 0101 112
- Hearing aid remote control application software
The SynGen™ DataTrak software is the application code that provides the interface between the operator and the SynGenX™-1000 System through a host PC computer. It downloads processing and system information from the CM and stores it in a database on the host PC computer. The data collected includes information gathered during each buffy coat harvest run including output of the accelerometer, infrared sensor readings, and timing and duration of the pinch and release of the cell transfer tubes. This collected data serves to document each processing run of the cord blood to support cGMP compliance.
Thermogenesis Corp.
SGI-0777
In Commercial Distribution
- B039SGI07770 ()
- Blood centrifugation system application software
The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
HEALTHY.IO LTD
WND PNT.EN.GEN
In Commercial Distribution
- 07290017272504 ()
- 17290017272877 ()
- Wound management image-analysis software
The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
HEALTHY.IO LTD
MNT WND.EN.GN2
In Commercial Distribution
- 07290017272504 ()
- 17290017272716 ()
- Wound management image-analysis software