Identity
- Trade Name
- M-VU ALGORITHM ENGINE FDA PMA
- Generic Name
- Analyzer, medical image FDA PMA
Identifiers
- PMA Number
- P100005 FDA PMA
- FDA Product Code
- MYN FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 892.2070 FDA PMA
- Regulation Number
- 892.2070 FDA PMA
- Advisory Committee
- Radiology FDA PMA
- FDA Decision
- APRL FDA PMA
The M-VU Algorithm Engine is a medical image analyzer designed to assist radiologists in screening mammography. It functions as a secondary review tool to identify areas within breast imaging that may be consistent with breast cancer, aiding in the detection process after an initial radiologic assessment.
This device is intended for use in radiology settings and operates as a software-based system. It is not described as single-use or reusable, nor are there indications of sterility or MRI safety requirements. The M-VU Algorithm Engine holds an FDA PMA approval (P100005) and is classified under device class II (MYN). No additional regulatory markings or special handling conditions are specified beyond its authorized use in screening mammography.
Frequently asked questions
What is the M-VU Algorithm Engine used for?
The M-VU Algorithm Engine is a medical image analyzer designed to assist radiologists in screening mammography by identifying areas that may be consistent with breast cancer after an initial radiologic assessment.
How is the M-VU Algorithm Engine supplied?
The device is supplied as a software-based system for use in radiology settings, with no specific information about packaging or physical components beyond its software nature.
Is the M-VU Algorithm Engine single-use or reusable?
The device is not described as single-use or reusable in the provided specifications, indicating it may be designed for multiple uses as a software system.
What regulatory approval does the M-VU Algorithm Engine have?
The M-VU Algorithm Engine holds FDA PMA approval (P100005) and is classified under device class II (MYN), specifically authorized for use in screening mammography to identify areas consistent with breast cancer.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P100005 | Class II | Active |
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Manufacturer
- Manufacturer
- Icad, Inc.
Sources (1)
- FDA PMA P100005 24 fields · synced Sep 18, 2026