Primary Device ID | 03770019599013 |
NIH Device Record Key | adbafd25-9981-48e1-8790-25112c5060a3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | inHEART Models Shaper |
Version Model Number | v1.2.0 |
Company DUNS | 269837780 |
Company Name | INHEART |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 9999999999 |
support@inheart.fr | |
Phone | 9999999999 |
support@inheart.fr | |
Phone | 9999999999 |
support@inheart.fr | |
Phone | 9999999999 |
support@inheart.fr | |
Phone | 9999999999 |
support@inheart.fr | |
Phone | 9999999999 |
support@inheart.fr | |
Phone | 9999999999 |
support@inheart.fr | |
Phone | 9999999999 |
support@inheart.fr | |
Phone | 9999999999 |
support@inheart.fr | |
Phone | 9999999999 |
support@inheart.fr | |
Phone | 9999999999 |
support@inheart.fr | |
Phone | 9999999999 |
support@inheart.fr | |
Phone | 9999999999 |
support@inheart.fr | |
Phone | 9999999999 |
support@inheart.fr | |
Phone | 9999999999 |
support@inheart.fr | |
Phone | 9999999999 |
support@inheart.fr |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03770019599013 [Primary] |
LMD | System, Digital Image Communications, Radiological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-04-14 |
Device Publish Date | 2021-04-06 |
03770019599020 - inHEART Models Explorer | 2023-10-18 inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export |
03770019599006 - inHEART Models Explorer | 2021-04-14 inHEART Models Explorer is a web-based visualization software for display, review, annotation and export of digital 3D models se |
03770019599013 - inHEART Models Shaper | 2021-04-14inHEART 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 Shaper | 2021-04-14 inHEART Models Shaper is a medical image processing and visualization software for manual 3D segmentation including cardiac imag |