Identity
- Trade Name
- Unfold AI FDA UDI
- Generic Name
- MRI image interpretive software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- v0.7.0 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850012642060 FDA UDI
- 510(k) Number
- K221624 FDA UDI
- FDA Product Code
- POK FDA UDI
- GMDN Term
- MRI image interpretive software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: MRI image interpretive software
Unfold AI by Avenda Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MRI image interpretive software.
- Mycardium — Mycardium AI Limited · Class II
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- QP-Prostate® CAD — QUIBIM SOCIEDAD LIMITADA. · Class II
- Bot Image, Inc. — Bot Image, Inc. · Class II
- Unfold AI — Avenda Health, Inc. · Class II
- Unfold AI — Avenda Health, Inc. · Class II
- Unfold AI — Avenda Health, Inc. · Class II
- Unfold AI — Avenda Health, Inc. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Avenda Health, Inc.
Sources (1)
- FDA UDI 67d45d05-4385-440f-bc62-ac1cb43c6d7e 34 fields · synced May 30, 2026