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

Image segmentation application software

• 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

Customer Support Contacts

• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr
• Phone: 9999999999
• Email: support@inheart.fr

Device Identifiers

Device Issuing Agency	Device ID
GS1	03770019599013 [Primary]

FDA Product Code

• LMD: System, Digital Image Communications, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-14
• Device Publish Date: 2021-04-06

On-Brand Devices [inHEART Models Shaper]

• 03770019599013: inHEART Models Shaper is a medical image processing and visualization software for manual 3D seg
• 03770019599082: inHEART MODELS Shaper is a standalone image processing software used to generate digital 3D mode
• 03770019599037: inHEART MODELS Shaper is a standalone image processing software used to generate digital 3D mode