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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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INFINITT ULite - 08809278790123

No Description
INFINITT Healthcare Co.,Ltd.
INFINITT ULite
In Commercial Distribution

  • 08809278790123 ()


  • Radiological PACS software

Xelis Dental - 08809278790116

No Description
INFINITT Healthcare Co.,Ltd.
Xelis Dental
In Commercial Distribution

  • 08809278790116 ()


  • Radiological PACS software

Xelis Cardiac - 08809278790109

No Description
INFINITT Healthcare Co.,Ltd.
Xelis Cardiac
In Commercial Distribution

  • 08809278790109 ()


  • Radiological PACS software

Xelis Fusion - 08809278790093

No Description
INFINITT Healthcare Co.,Ltd.
Xelis Fusion
In Commercial Distribution

  • 08809278790093 ()


  • Radiological PACS software

Xelis 3D - 08809278790086

No Description
INFINITT Healthcare Co.,Ltd.
Xelis 3D
In Commercial Distribution

  • 08809278790086 ()


  • Radiological PACS software

Xelis - 08809278790079

No Description
INFINITT Healthcare Co.,Ltd.
Xelis
In Commercial Distribution

  • 08809278790079 ()


  • Radiological PACS software

INFINITT Cardiology PACS - 08809278790062

No Description
INFINITT Healthcare Co.,Ltd.
INFINITT Cardiology PACS
In Commercial Distribution

  • 08809278790062 ()


  • Radiological PACS software

INFINITT PACS, INFINITT G3, INFINITT Mammo - 08809278790055

No Description
INFINITT Healthcare Co.,Ltd.
INFINITT PACS
In Commercial Distribution

  • 08809278790055 ()


  • Radiological PACS software

Reformat Gateway - 08809278790048

No Description
INFINITT Healthcare Co.,Ltd.
Reformat Gateway
In Commercial Distribution

  • 08809278790048 ()


  • Radiological PACS software

STARPACS Dental - 08809278790031

No Description
INFINITT Healthcare Co.,Ltd.
STARPACS Dental
In Commercial Distribution

  • 08809278790031 ()


  • Radiological PACS software

RapidiaColon System - 08809278790024

No Description
INFINITT Healthcare Co.,Ltd.
RapidiaColon System
In Commercial Distribution

  • 08809278790024 ()


  • Radiological PACS software

STARPACS Orthopedics System - 08809278790017

No Description
INFINITT Healthcare Co.,Ltd.
STARPACS Orthopedics System
In Commercial Distribution

  • 08809278790017 ()


  • Radiological PACS software

STARPACS - 08809278790000

No Description
INFINITT Healthcare Co.,Ltd.
STARPACS
In Commercial Distribution

  • 08809278790000 ()


  • Radiological PACS software

Avatar Generation - 04250668606670

N/A
Carl Zeiss Vision GmbH
000000-2351-295
Not in Commercial Distribution

  • 04250668606670 ()
000000-2351-295

  • Camera application software

WAVENET - 00380659908170

ALLEGRETTO WAVE EYE-Q EXCIMER
Alcon Laboratories, Inc.
8065990817
Not in Commercial Distribution

  • 00380659908170 ()
8065990817

  • Laser application software

Biovitals Analytics Engine - 08885018690021

No Description
BIOFOURMIS SINGAPORE PTE. LTD.
2.0
In Commercial Distribution

  • 08885018690021 ()


  • Physiologic monitor-installed software

SagiPlan® with prostate module - 04065983000047

SagiPlan® is a Brachytherapy Treatment Planning System used by medical professionals. SagiPlan® is used for the creation of treatment plans for remote afterloader based HDR brachytherapy. SagiPlan® will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan® also supports the evaluation of clinical images in calculating the dose for organs at risk and target volumes. SagiPlan® especially supports the SagiNova (Multisource and GyneSource) Brachytherapy Remote Controlled Afterloading Devices from BEBIG Medical GmbH (Eckert & Ziegler BEBIG GmbH).
BEBIG Medical GmbH
06
In Commercial Distribution

  • 04065983000047 ()
1374-0610

  • Radiation therapy software

SagiPlan® - 04065983000016

SagiPlan® is a Brachytherapy Treatment Planning System used by medical professionals. SagiPlan® is used for the creation of treatment plans for remote afterloader based HDR brachytherapy. SagiPlan® will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan® also supports the evaluation of clinical images in calculating the dose for organs at risk and target volumes. SagiPlan® especially supports the SagiNova (Multisource and GyneSource) Brachytherapy Remote Controlled Afterloading Devices from BEBIG Medical GmbH (Eckert & Ziegler BEBIG GmbH).
BEBIG Medical GmbH
06
In Commercial Distribution

  • 04065983000016 ()
1374-0600

  • Radiation therapy software

MSPT v3.0 - 00195893702190

No Description
Qr8 Health Inc
MSPT-30
Not in Commercial Distribution

  • 00195893702190 ()


  • Cognitive assessment software

MSPT Web v3.0 - 00195893329458

No Description
Qr8 Health Inc
MSPT-W30
Not in Commercial Distribution

  • 00195893329458 ()


  • Cognitive assessment software

QuantorView - 08809466041112

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

Merge OrthoPACS - 00842000100706

No Description
MERGE HEALTHCARE SOLUTIONS INC.
7.3
In Commercial Distribution

  • 00842000100706 ()


  • Radiological PACS software

Merge OrthoPACS - 00842000100676

No Description
MERGE HEALTHCARE SOLUTIONS INC.
7.2
In Commercial Distribution

  • 00842000100676 ()


  • Radiological PACS software

eFilm Workstation - 00842000100652

No Description
MERGE HEALTHCARE SOLUTIONS INC.
4.2.1
Not in Commercial Distribution

  • 00842000100652 ()


  • Radiological PACS software

eFilm Lite - 00842000100300

No Description
MERGE HEALTHCARE SOLUTIONS INC.
4.2.1
Not in Commercial Distribution

  • 00842000100300 ()


  • Radiological PACS software

Merge Eye Station - 00842000100140

No Description
MERGE HEALTHCARE SOLUTIONS INC.
11.6.1
Not in Commercial Distribution

  • 00842000100140 ()


  • Radiological PACS software

Merge PACS - 00842000100478

No Description
MERGE HEALTHCARE SOLUTIONS INC.
7.1.2.1
In Commercial Distribution

  • 00842000100478 ()


  • Radiological PACS software

Merge Unity Pacs - 00842000100461

No Description
MERGE HEALTHCARE SOLUTIONS INC.
11.0
In Commercial Distribution

  • 00842000100461 ()


  • Radiological PACS software

Merge OrthoPACS - 00842000100454

No Description
MERGE HEALTHCARE SOLUTIONS INC.
7.1.2.1
In Commercial Distribution

  • 00842000100454 ()


  • Radiological PACS software

iConnect Enterprise Workflow with Merge PACS - 00842000100133

Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform.
MERGE HEALTHCARE SOLUTIONS INC.
1.0
In Commercial Distribution

  • 00842000100133 ()


  • Radiological PACS software

AiD Regen - 08809692507000

No Description
ROKIT HEALTHCARE Inc.
AIDR-001
In Commercial Distribution

  • 08809692507000 ()


  • CAD/CAM software

SpassageQ - 08809957910002

The SpassageQ is a SaMD that automatically calculates the patient’s qSOFA score based on the six vital signs received from the HL7 gateway system and the GCS directly entered by the healthcare provider and notifies the user of signs of sepsis through visual alarms.
Spass Co.,Ltd.
1.0.0
In Commercial Distribution

  • 08809957910002 ()


  • Physiologic monitor-installed software

RT Elements - 04056481146030

No Description
Brainlab AG
4.5
In Commercial Distribution

  • 04056481146030 ()


  • Radiation therapy software

ExacTrac Dynamic - 04056481144609

No Description
Brainlab AG
2.0
In Commercial Distribution

  • 04056481144609 ()


  • Radiation therapy software

RT Elements - 04056481144494

No Description
Brainlab AG
4.0
In Commercial Distribution

  • 04056481144494 ()


  • Radiation therapy software

ExacTrac Dynamic - 04056481143978

No Description
Brainlab AG
1.1
In Commercial Distribution

  • 04056481143978 ()


  • Radiation therapy software

ViewPoint - 00195278753472

ViewPoint 6 v6.15
GE Healthcare GmbH
6. ver15
In Commercial Distribution

  • 00195278753472 ()
H47601AA

  • Radiological PACS software

syngo Dynamics - 04056869272320

syngo Dynamics VA20I Medical Device Identifier
Siemens Healthcare GmbH
11552102
In Commercial Distribution

  • 04056869272320 ()


  • Radiological PACS software

syngo Dynamics - 04056869272313

syngo Dynamics VA20I Packaging Label
Siemens Healthcare GmbH
11552103
In Commercial Distribution

  • 04056869272313 ()


  • Radiological PACS software

syngo Dynamics - 04056869259901

syngo Dynamics VA20H Package Label
Siemens Healthcare GmbH
11551864
In Commercial Distribution

  • 04056869259901 ()


  • Radiological PACS software

AI-Rad Companion Organs RT - 04056869257969

AI-Rad Companion Organs RT About Box
Siemens Healthcare GmbH
11294433
Not in Commercial Distribution

  • 04056869257969 ()


  • Radiological PACS software

syngo Dynamics - 04056869256399

syngo Dynamics VA20H
Siemens Healthcare GmbH
11551643
In Commercial Distribution

  • 04056869256399 ()


  • Radiological PACS software

syngo Utrasound Breast Analysis - 04056869250144

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11507859
In Commercial Distribution

  • 04056869250144 ()


  • Radiological PACS software

syngo Dynamics VA20G Packaging Label - 04056869247175

No Description
Siemens Healthcare GmbH
10745653
In Commercial Distribution

  • 04056869247175 ()


  • Radiological PACS software

syngo Dynamics VA20G - 04056869247144

No Description
Siemens Healthcare GmbH
10745650
In Commercial Distribution

  • 04056869247144 ()


  • Radiological PACS software

syngo Ultrasound Apps Suite (sUSAS) - 04056869235417

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11291194
In Commercial Distribution

  • 04056869235417 ()


  • Radiological PACS software

syngo Dynamics - 04056869227054

syngo Dynamics VA20F CD Label
Siemens Healthcare GmbH
10745437
In Commercial Distribution

  • 04056869227054 ()


  • Radiological PACS software

syngo Dynamics - 04056869227047

syngo Dynamics VA20F Workplace Installer CD Label
Siemens Healthcare GmbH
10745438
In Commercial Distribution

  • 04056869227047 ()


  • Radiological PACS software

syngo Dynamics - 04056869227030

syngo Dynamics VA20F Product Label - About Box
Siemens Healthcare GmbH
10745495
In Commercial Distribution

  • 04056869227030 ()


  • Radiological PACS software

syngo Dynamics - 04056869227023

syngo Dynamics VA20F Packaging Label
Siemens Healthcare GmbH
10745496
In Commercial Distribution

  • 04056869227023 ()


  • Radiological PACS software
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