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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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ManoView - 07290101365778

v3.0.1 Software kit
Given Imaging, Inc.
FGS-8028
In Commercial Distribution

  • 07290101365778 ()


  • Manometric gastrointestinal motility analysis system

Mano Scan - 07290101365754

ManoScan ESO Software
Given Imaging, Inc.
800022
In Commercial Distribution

  • 07290101365754 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101364009

ManoScan AR Software
Given Imaging, Inc.
800024
In Commercial Distribution

  • 07290101364009 ()


  • Manometric gastrointestinal motility analysis system

SmartPill - 07290110360481

SmartPill software v3.1
Given Imaging, Inc.
FGS-0658
In Commercial Distribution

  • 07290110360481 ()


  • Gastrointestinal telemetric monitoring system

Reflux - 07290110360429

Reflux software v6.1
Given Imaging, Inc.
FGS-0656
In Commercial Distribution

  • 07290110360429 ()


  • Gastrointestinal telemetric monitoring system

LATITUDE® Clarity - 00802526613838

Device Services Software
BOSTON SCIENTIFIC CORPORATION
7260
In Commercial Distribution

  • 00802526613838 ()
7260

  • Patient health record information system application software

Navios Analysis Software - 15099590512453

Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774953
In Commercial Distribution

  • 15099590512453 ()
774953

  • Laboratory instrument/analyser application software IVD

Navios Analysis Software - 15099590512125

Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774951
In Commercial Distribution

  • 15099590512125 ()
774951

  • Laboratory instrument/analyser application software IVD

Navios Analysis Software - 15099590512118

Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774952
In Commercial Distribution

  • 15099590512118 ()
774952

  • Laboratory instrument/analyser application software IVD

Navios tetra Software - 15099590510756

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

  • 15099590510756 ()
775213

  • Laboratory instrument/analyser application software IVD

Vyaire - 34250892904161

Spirometry PC Software
Jaeger Medical GmbH
2.5
In Commercial Distribution

  • 34250892904161 ()
36-SPC1000-STK

  • Pulmonary function analysis system, adult

MicroMedical - 34250892901603

Spirometry PC Software
Jaeger Medical GmbH
2.5
Not in Commercial Distribution

  • 34250892901603 ()
36-SPC1000-STK

  • Pulmonary function analysis system, adult

Spirometry PC Software - 34250892980233

Spirometry PC Software
CAREFUSION U.K. 232 LIMITED
2.5
Not in Commercial Distribution

  • 34250892980233 ()
36-SPC1000-STK

  • Pulmonary function analysis system, adult

Dental Imaging Software - 60889975319575

DENTAL IMAGING SOFTWARE
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889975319575 ()
5319579

  • General-purpose dental x-ray system application software

MAXUM - M737M61021

Packaged OptiMAX Software
Ototronix, LLC
M6102
In Commercial Distribution

  • M737M61021 ()


  • Partially-implantable middle ear implant system

Welch Allyn, Inc. - 00732094128482

PCH100 STANDALONE SOFTWARE
WELCH ALLYN, INC.
901052
In Commercial Distribution

  • 00732094128482 ()
704525

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094312812

Software ELI LINK
WELCH ALLYN, INC.
901147
In Commercial Distribution

  • 00732094312812 ()
107347

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094281330

SOFTWARE HSCRIBE v6.2.0
WELCH ALLYN, INC.
901000
In Commercial Distribution

  • 00732094281330 ()
11110-003-50

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094272352

Q-STRESS SOFTWARE V4.60
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094272352 ()
11090-001-50

  • Electrocardiographic lead set, reusable

QLAB Advanced Quantification Software - 00884838103603

Software Revision 15.5
Philips Ultrasound LLC
989606720441
In Commercial Distribution

  • 00884838103603 ()


  • Radiological PACS software

IntelliVue XDS Software - 00884838092099

IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software
In Commercial Distribution

  • 00884838092099 ()
867019

  • Bedside information system application software

IntelliVue XDS Software - 00884838059313

IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software
In Commercial Distribution

  • 00884838059313 ()
867019

  • Bedside information system application software

IntelliVue XDS Software - 00884838123175

IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software - R
In Commercial Distribution

  • 00884838123175 ()
867019

  • Bedside information system application software

Affinti 70 Diaagnostic Ultrasound System Circular Edition - 00884838114258

Software Version 10.0.2
Philips Ultrasound LLC
795119
In Commercial Distribution

  • 00884838114258 ()


  • General-purpose ultrasound imaging system

Affinti 50 Diaagnostic Ultrasound System Circular Edition - 00884838114241

Software Version 10.0.2
Philips Ultrasound LLC
795118
In Commercial Distribution

  • 00884838114241 ()


  • General-purpose ultrasound imaging system

EPIQ 5 Diagnostic Ultrasound System - 00884838114111

Software version-10.0.X
Philips Ultrasound LLC
795204
In Commercial Distribution

  • 00884838114111 ()


  • General-purpose ultrasound imaging system

IntelliVue XDS Software - 00884838109957

IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software
In Commercial Distribution

  • 00884838109957 ()
867019

  • Bedside information system application software

EPIQ 5W Diagnostic Ultrasound System - 00884838114128

Software version-10.0.X
Philips Ultrasound LLC
795204
In Commercial Distribution

  • 00884838114128 ()
795206

  • General-purpose ultrasound imaging system

PULSE - 00195377065544

PULSE Software, v4.0.0-bln.eu
Nuvasive, Inc.
1802497
In Commercial Distribution

  • 00195377065544 ()


  • Orthopaedic stereotactic surgery system

PULSE - 00195377065537

PULSE Software, v4.0.0-bln.us
Nuvasive, Inc.
1802495
In Commercial Distribution

  • 00195377065537 ()


  • Orthopaedic stereotactic surgery system

PULSE - 00195377065520

PULSE Software, v4.0.0-bl.eu
Nuvasive, Inc.
1802493
In Commercial Distribution

  • 00195377065520 ()


  • Orthopaedic stereotactic surgery system

PULSE - 00195377065513

PULSE Software, v4.0.0-bl.us
Nuvasive, Inc.
1802491
In Commercial Distribution

  • 00195377065513 ()


  • Orthopaedic stereotactic surgery system

Clarity® - 07540180000221

Clarity® Software
Elekta Solutions AB
9310-00044
In Commercial Distribution

  • 07540180000221 ()


  • Ultrasound patient positioning system

True Lok System - 18054242511847

TL-HEX APPLICATION SOFTWARE
ORTHOFIX SRL
01
In Commercial Distribution

  • 18054242511847 ()
TLHEXSW

  • External orthopaedic fixation frame calculation software

ILLUMISITE - 10884521779990

Planning Software V1.0
Covidien LP
Planning Application V1.0
In Commercial Distribution

  • 10884521779990 ()


  • Electromagnetic surgical navigation device tracking system

ILLUMISITE - 10884521779983

Procedure Software V1.0
Covidien LP
Procedure Application V1.0
In Commercial Distribution

  • 10884521779983 ()


  • Electromagnetic surgical navigation device tracking system

superDimension - 10884521747432

v7.1 Planning Software
Covidien LP
PMB00569-01
In Commercial Distribution

  • 10884521747432 ()


  • Electromagnetic surgical navigation device tracking system

superDimension - 10884521747425

v7.2 Procedure Software
Covidien LP
PMB00667-01
In Commercial Distribution

  • 10884521747425 ()


  • Electromagnetic surgical navigation device tracking system

syngo Application Software Media - 04056869025902

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

Eureka - B220843002A8430031

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

ClariPlatform - 08800046800167

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 - 08800046800150

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

Norav 1200 Series PC-ECG - 07290110252779

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2
In Commercial Distribution

  • 07290110252779 ()
HASP-SW-K-S2-01

  • Cardiopulmonary stress exercise monitoring system computer

FUKUDA DENSHI - 04538612915154

No Description
FUKUDA DENSHI CO.,LTD.
FP-811
In Commercial Distribution

  • 04538612915154 ()


  • Software upgrade/unlocking key

FUKUDA DENSHI - 04538612916014

No Description
FUKUDA DENSHI CO.,LTD.
FP-908LP
In Commercial Distribution

  • 04538612916014 ()


  • Software upgrade/unlocking key

FUKUDA DENSHI - 04538612916007

No Description
FUKUDA DENSHI CO.,LTD.
FP-908A
In Commercial Distribution

  • 04538612916007 ()


  • Software upgrade/unlocking key

UPGRADE KIT FOR UCES-3 (Version 4) - 04953170335464

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2051
Not in Commercial Distribution

  • 04953170335464 ()


  • Software upgrade/unlocking key

OTV-S500 UPGRADE PACK STROBE - 04953170458170

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2547
In Commercial Distribution

  • 04953170458170 ()
N6216940

  • Software upgrade/unlocking key

OTV-S700 UPGRADE PACK 3D - 04953170445453

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2511
In Commercial Distribution

  • 04953170445453 ()
N6189440

  • Software upgrade/unlocking key

SWQ SOFTWARE OPTION - 04953170431906

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2383
In Commercial Distribution

  • 04953170431906 ()
N6157530

  • Software upgrade/unlocking key
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