inHEART Models Explorer

GUDID 03770019599020

inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART MODELS Shaper. inHEART Models Explorer 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 clinicians are solely responsible for making all final patient management decisions.

INHEART

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• Primary Device ID: 03770019599020
• NIH Device Record Key: 902f9cb9-f215-4c27-8d7c-62e31fa557eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: inHEART Models Explorer
• Version Model Number: v2.5.0
• 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: false
• 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	03770019599020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220727

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-18
• Device Publish Date: 2022-12-12

On-Brand Devices [inHEART Models Explorer]

• 03770019599006: inHEART Models Explorer is a web-based visualization software for display, review, annotation an
• 03770019599020: inHEART Models Explorer is a a web-based 3D visualization software that permits display, review,
• 03770019599099: inHEART Models Explorer is a a web-based 3D visualization software that permits display, review,