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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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Navios tetra Software
BECKMAN COULTER IRELAND INC.
775213
In Commercial Distribution

  • 15099590510756 ()
775213

  • Laboratory instrument/analyser application software IVD
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-811
In Commercial Distribution

  • 04538612915154 ()


  • Software upgrade/unlocking key
No Description
FUKUDA DENSHI CO.,LTD.
FP-908A
In Commercial Distribution

  • 04538612916007 ()


  • Software upgrade/unlocking key
Pure Vue Software expansion
Medos International Sàrl
242329
In Commercial Distribution

  • 10886705032204 ()
242329

  • Software upgrade/unlocking key
CARD MULTIMEDIA DTS
DJO, LLC
2842
In Commercial Distribution

  • 00888912296533 ()


  • Software upgrade/unlocking key
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2305
In Commercial Distribution

  • 04953170396021 ()
N5769640

  • Software upgrade/unlocking key
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2304
In Commercial Distribution

  • 04953170395994 ()


  • Software upgrade/unlocking key
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2303
In Commercial Distribution

  • 04953170395963 ()


  • Software upgrade/unlocking key
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2051
Not in Commercial Distribution

  • 04953170335464 ()


  • Software upgrade/unlocking key
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2547
In Commercial Distribution

  • 04953170458170 ()
N6216940

  • Software upgrade/unlocking key
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2511
In Commercial Distribution

  • 04953170445453 ()
N6189440

  • Software upgrade/unlocking key
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2383
In Commercial Distribution

  • 04953170431906 ()
N6157530

  • Software upgrade/unlocking key
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2382
In Commercial Distribution

  • 04953170431890 ()
N6157430

  • Software upgrade/unlocking key
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