INHEART

Address:IHU Liryc - Hopital Xavier Arnozan,Pessac Gironde,FR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Digital Image Communications, Radiological (LMD) (2)

Premarket Exempt

Yes

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inHEART Models Explorer - 03770019599006 Catalog Number :

Device Description : inHEART Models Explorer is a web-based visualization software for display, revie inHEART Models Explorer is a web-based visualization software for display, review, annotation and export of digital 3D models segmented from medical images including cardiac images (CT and/or MR). It is intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians), as well as by inHEART trained staffs.inHEART Models Explorer is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians).Clinicians are solely responsible for making all final patient management decisions.

Device Class : 1

Duns Number: 269837780

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

inHEART Models Shaper - 03770019599013 Catalog Number :

Device Description : inHEART Models Shaper is a medical image processing and visualization software f inHEART Models Shaper is a medical image processing and visualization software for manual 3D segmentation including cardiac images. It provides simple image review software functionality for basic medical image processing and manipulation, such as grayscale window and level, zoom and pan, image reformat, thresholding or user delineated geometric measurements (distance and volume). It is intended to be used by inHEART trained staffs.inHEART Models Shaper is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians).Clinicians are solely responsible for making all final patient management decisions.