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Web based software
MYCARDIO LLC
8
Not in Commercial Distribution
- B315SLEEPIMAGECOM0 ()
- Multiple physiological signal amplifier
Central Server Software
Lifesignals, Inc.
UA2550-S
In Commercial Distribution
- B353UA2550S1 ()
- Network server
Relay Bridge Software
Lifesignals, Inc.
UA2550-RB
In Commercial Distribution
- B353UA2550RB1 ()
- Physiological measuring device wireless data capture/transfer unit
Bluetooth Gateway Software
Lifesignals, Inc.
UA2550-BG
In Commercial Distribution
- B353UA2550BG1 ()
- Physiological measuring device wireless data capture/transfer unit
StereoCalc 2.0 Software
INTEGRA LIFESCIENCES CORPORATION
SCSWCD
Not in Commercial Distribution
- M248SCSWCD1 ()
- 10381780252610 ()
SC SW CD
- Neurological stereotactic surgery system
MyShoulder Planner Software
Medacta International SA
5.3SSWPL
In Commercial Distribution
- 07630542730153 ()
- Orthopaedic/craniofacial implantation planning software
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
C.0.4 Software Upgrade
In Commercial Distribution
- 00812059021536 ()
15211-01
- Coronary optical coherence tomography system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
D.1 Software
In Commercial Distribution
- 00812059021482 ()
100074942
- Coronary optical coherence tomography system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
Integrated System E.2 Software
In Commercial Distribution
- 00812059021390 ()
C408657
- Coronary optical coherence tomography system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
OPTIS™ E.2 Software
In Commercial Distribution
- 00812059021383 ()
C408656
- Coronary optical coherence tomography system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
D.1.1 Software
In Commercial Distribution
- 00812059020560 ()
100111860
- Coronary optical coherence tomography system
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-010-51
In Commercial Distribution
- 00812345025217 ()
- Patient health record information system
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-001-50
In Commercial Distribution
- 00812345024708 ()
- Cardiology information system application software
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-010-50
In Commercial Distribution
- 00812345023459 ()
- Patient health record information system
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-001-51
In Commercial Distribution
- 00812345024715 ()
- Cardiology information system application software
CuattroDR System Software
Cuattro Medical
SWR-00069-MD
In Commercial Distribution
- B269SWR00069MD0 ()
- Stationary basic diagnostic x-ray system, digital
Synergy.net Management Software
ARTHREX, INC.
AR-3200-1030
In Commercial Distribution
- 00888867100626 ()
AR-3200-1030
- Operating room audiovisual data/device management system
Clinician Programmer Software
BIONESS INC.
ST2-SW01
In Commercial Distribution
- 00815962020306 ()
- Transcutaneous electrical stimulation probe
Clinician Programmer Software
BIONESS INC.
H2W-SW01
In Commercial Distribution
- 00815962020290 ()
- Hand orthosis
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-002-51
In Commercial Distribution
- 00817655020259 ()
- Cardiology information system application software
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-002-50
In Commercial Distribution
- 00817655020242 ()
- Cardiology information system application software
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-51
In Commercial Distribution
- 00817655022802 ()
- Patient health record information system
TL-HEX APPLICATION SOFTWARE
ORTHOFIX SRL
01
In Commercial Distribution
- 18054242511847 ()
TLHEXSW
- External orthopaedic fixation frame calculation software
SmartPill software v3.1
Given Imaging, Inc.
FGS-0658
In Commercial Distribution
- 07290110360481 ()
- Gastrointestinal telemetric monitoring system
Reflux software v6.1
Given Imaging, Inc.
FGS-0656
In Commercial Distribution
- 07290110360429 ()
- Gastrointestinal telemetric monitoring system
v3.0 software kit
Given Imaging, Inc.
FGS-0571
In Commercial Distribution
- 07290101365921 ()
- Manometric gastrointestinal motility analysis system
v3.0.1 Software kit
Given Imaging, Inc.
FGS-8028
In Commercial Distribution
- 07290101365778 ()
- Manometric gastrointestinal motility analysis system
ManoScan ESO Software
Given Imaging, Inc.
800022
In Commercial Distribution
- 07290101365754 ()
- Manometric gastrointestinal motility analysis system
ManoScan AR Software
Given Imaging, Inc.
800024
In Commercial Distribution
- 07290101364009 ()
- Manometric gastrointestinal motility analysis system
Device Services Software
BOSTON SCIENTIFIC CORPORATION
7260
In Commercial Distribution
- 00802526613838 ()
7260
- Patient health record information system application software
Clarity® Software
Elekta Solutions AB
9310-00044
In Commercial Distribution
- 07540180000221 ()
- Ultrasound patient positioning system
Clarity® Software
Elekta Ltd
9310-00043
In Commercial Distribution
- 07540180000207 ()
- Ultrasound patient positioning system
Clarity® Software
Elekta Ltd
9310-00042
In Commercial Distribution
- 07540180000184 ()
- Ultrasound patient positioning system
Spirometry PC Software
Jaeger Medical GmbH
2.5
In Commercial Distribution
- 34250892904161 ()
36-SPC1000-STK
- Pulmonary function analysis system, adult
Spirometry PC Software
CAREFUSION U.K. 232 LIMITED
2.5
Not in Commercial Distribution
- 34250892980233 ()
36-SPC1000-STK
- Pulmonary function analysis system, adult
Spirometry PC Software
Jaeger Medical GmbH
2.5
Not in Commercial Distribution
- 34250892901603 ()
36-SPC1000-STK
- Pulmonary function analysis system, adult
Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774953
In Commercial Distribution
- 15099590512453 ()
774953
- Laboratory instrument/analyser application software IVD
Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774951
In Commercial Distribution
- 15099590512125 ()
774951
- Laboratory instrument/analyser application software IVD
Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774952
In Commercial Distribution
- 15099590512118 ()
774952
- Laboratory instrument/analyser application software IVD
Navios tetra Software
BECKMAN COULTER IRELAND INC.
775213
In Commercial Distribution
- 15099590510756 ()
775213
- Laboratory instrument/analyser application software IVD
SOFTWARE HSCRIBE v6.2.0
WELCH ALLYN, INC.
901143
In Commercial Distribution
- 00732094281330 ()
11110-003-50
- Electrocardiographic long-term ambulatory recording analyser application software
syngo Application Software VD1;syngo Application Software Media;Registered Medical Devices:syngo Application Software – GTIN 04056869012902
Siemens Healthcare GmbH
10849116
In Commercial Distribution
- 04056869025902 ()
- Basic diagnostic x-ray system application software
syngo Application Software VD1,syngo Application Software KIT,Registered Medical Devices,syngo Application Software GTIN 04056869012902
Siemens Healthcare GmbH
10849112
In Commercial Distribution
- 04056869025919 ()
- Basic diagnostic x-ray system application software
MUCheck® Independent Dose Calculation Software. MUCheck® Software. MUCheck® Software Suite. Oncology Data Systems, Inc.
Oncology Data Systems Inc
MUCheck®
In Commercial Distribution
- 00860175002403 ()
- Radiation therapy software
ClariPlatform (Ver. ClariSuite View) is a medical imaging platform that hosts clinical AI solutions and provides user interface in an on-premise environment.
The system facilitates the networking, filtering, routing, and optional de-identification of medical image data between imaging systems, allowing users to easily execute AI solutions on-demand or integrate them into their clinical workflow. Additionally the system allows users to interact with the AI analysis results including confirming, rejecting, and selecting other category than provided by AI.
While ClariPlatform (Ver.1.0) operates as a cloud-based system, ClariPlatform (Ver. ClariSuite View) is specifically designed for on-premise deployment, ensuring compliance with institutional security policies, regulatory requirements, and data privacy concerns. ClariPlatform (Ver. ClariSuite View) is deployed within anorganization’s internal infrastructure, allowing healthcare providers to maintain full control over medical imaging data while leveraging advanced AI-assisted visualization tools.
Clinical AI solutions refer to separate medical device software and are not included within the scope of this system.
ClariPI Inc.
ClariSuite View
In Commercial Distribution
- 08800046800167 ()
- Radiological image interpretive software sharing portal
ClariPlatform (Ver. 1.0) is a medical imaging platform that hosts clinical AI solutions in a cloud-based SaaS format.
The system facilitates the networking, filtering, routing, and de-identification of medical image data between imaging systems, allowing users to easily execute AI solutions on-demand or integrate them into their clinical workflow.
ClariPlatform is only deployed on the cloud, ensuring accessibility and compliance with regulations.
Clinical AI solutions refer to separate medical device software and are not included within the scope of this system.
ClariPI Inc.
1.0
In Commercial Distribution
- 08800046800150 ()
- Radiological image interpretive software sharing portal
An application software program designed to function as a portal to allow software providers to make available radiological interpretive software [typically artificial intelligence (AI) based] for radiology professionals to access, use, evaluate, and compare. It is intended to facilitate distribution and hospital implementation of algorithms designed to assist image interpretation within a healthcare facility.
Terarecon Inc.
Eureka AI Interoperability Platform
In Commercial Distribution
- B220843002A8430031 ()
- Radiological image interpretive software sharing portal
No Description
FUKUDA DENSHI CO.,LTD.
FP-908LP
In Commercial Distribution
- 04538612916014 ()
- Software upgrade/unlocking key
No Description
FUKUDA DENSHI CO.,LTD.
FP-908A
In Commercial Distribution
- 04538612916007 ()
- Software upgrade/unlocking key
No Description
FUKUDA DENSHI CO.,LTD.
FP-811
In Commercial Distribution
- 04538612915154 ()
- Software upgrade/unlocking key