inHEART MODELS Shaper

GUDID 03770019599082

inHEART MODELS Shaper is a standalone image processing software used to generate digital 3D models of the patient heart from medical images acquired by CT and/or MR devices. inHEART MODELS Shaper 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 users are solely responsible for making all final patient management decisions.

INHEART

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• Primary Device ID: 03770019599082
• NIH Device Record Key: cd3c4e5f-688e-436e-806c-d332e930ca5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: inHEART MODELS Shaper
• Version Model Number: v1.8.0
• Company DUNS: 269837780
• Company Name: INHEART
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03770019599082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231683

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2024-04-16
• Device Publish Date: 2024-04-08

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