Unfold AI

GUDID 00850012642091

The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.

Avenda Health, Inc.

MRI image interpretive software

• Primary Device ID: 00850012642091
• NIH Device Record Key: c4aeff5f-864d-4738-b7a5-4f61a933ba1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unfold AI
• Version Model Number: v0.10.0
• Company DUNS: 102268407
• Company Name: Avenda Health, Inc.
• 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: false
• 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	00850012642091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221624

FDA Product Code

• POK: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

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: 2025-10-07
• Device Publish Date: 2025-09-29

On-Brand Devices [Unfold AI]

• 00850012642015: The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support s
• 00850012642022: The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support s
• 00850012642039: The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support s
• 00850012642046: The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support s
• 00850012642053: The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support s
• 00850012642060: The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support s
• 00850012642077: The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support s
• 00850012642084: The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support s
• 00850012642091: The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support s