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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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Dental Imaging Software - 60889971045072

Dental Imaging software update only
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889971045072 ()
1045079

  • General-purpose dental x-ray system application software

ICUpilot Software eng - 07332699000751

No Description
M DIALYSIS INC.
English
In Commercial Distribution

  • 07332699000751 ()
8001027

  • Bedside information system

QLAB Quantification Software - 00884838070837

No Description
Philips Ultrasound LLC
Release 10.7
In Commercial Distribution

  • 00884838070837 ()


  • Radiological PACS software

QLAB Quantification Software - 00884838059788

No Description
Philips Ultrasound LLC
Release 10.5
In Commercial Distribution

  • 00884838059788 ()


  • Radiological PACS software

Qlab Quantification Software - 00884838098220

Version 15.0
Philips Ultrasound LLC
989606710071
In Commercial Distribution

  • 00884838098220 ()


  • Radiological PACS software

QLAB Quantification Software - 00884838086616

No Description
Philips Ultrasound LLC
Release 10.8.5
In Commercial Distribution

  • 00884838086616 ()


  • Radiological PACS software

Q-Station Application Software - 00884838083509

No Description
Philips Ultrasound LLC
Release 3.8
In Commercial Distribution

  • 00884838083509 ()


  • Radiological PACS software

inHEART MODELS AI - 03770019599075

inHEART MODELS AI is a medical image processing software for automatic 3D modelling, used to pre-process medical images (acquired only by CT devices). inHEART Models AI results are intended to be reviewed and, if needed, edited by inHEART trained staff with inHEART Models Shaper. inHEART MODELS AI is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions.
INHEART
v1.1.0
In Commercial Distribution

  • 03770019599075 ()


  • Image segmentation application software

BIS - 10884521808317

BIS (TM) Advance Monitor
Covidien LP
PMB4000ACBL
In Commercial Distribution

  • 10884521808317 ()


  • Analytical scalp lead

BIS - 10884521808300

BIS (TM) Advance Docking Station
Covidien LP
PMB4000DOC
In Commercial Distribution

  • 10884521808300 ()


  • Anaesthesia depth monitor
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