inHEART Models Shaper

GUDID 03770019599013

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.

INHEART

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Primary Device ID03770019599013
NIH Device Record Keyadbafd25-9981-48e1-8790-25112c5060a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameinHEART Models Shaper
Version Model Numberv1.2.0
Company DUNS269837780
Company NameINHEART
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9999999999
Emailsupport@inheart.fr
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Emailsupport@inheart.fr
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Emailsupport@inheart.fr
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Emailsupport@inheart.fr
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Emailsupport@inheart.fr
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Emailsupport@inheart.fr
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Emailsupport@inheart.fr
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Emailsupport@inheart.fr
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Emailsupport@inheart.fr

Device Identifiers

Device Issuing AgencyDevice ID
GS103770019599013 [Primary]

FDA Product Code

LMDSystem, Digital Image Communications, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-14
Device Publish Date2021-04-06

Devices Manufactured by INHEART

03770019599020 - inHEART Models Explorer2023-10-18 inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export
03770019599006 - inHEART Models Explorer2021-04-14 inHEART Models Explorer is a web-based visualization software for display, review, annotation and export of digital 3D models se
03770019599013 - inHEART Models Shaper2021-04-14inHEART 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.
03770019599013 - inHEART Models Shaper2021-04-14 inHEART Models Shaper is a medical image processing and visualization software for manual 3D segmentation including cardiac imag

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