M-VU ALGORITHM ENGINE
FDA premarket approval P100005 · decided 2012-01-23
Approval details
- PMA number
- P100005
- Trade name
- M-VU ALGORITHM ENGINE
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2010-02-01
- Decision date
- 2012-01-23
- Days to decision
- 721 days
- Decision code
- APRL
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR THE M-VU ALGORITHM ENGINE. THE DEVICE IS INDICATED FOR USE IN SCREENING MAMMOGRAPHY TO IDENTIFY AREAS CONSISTENT WITH BREAST CANCER FOR RADIOLOGIST REVIEW AFTER COMPLETING AN INITIAL READ.
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