BREAST COMPANION SOFTWARE SYSTEM
FDA premarket approval P100007 · decided 2012-02-10
Approval details
- PMA number
- P100007
- Trade name
- BREAST COMPANION SOFTWARE SYSTEM
- Generic name
- Analyzer, medical image
- Applicant
- Almen Laboratories, Inc.
- Date received
- 2010-02-17
- Decision date
- 2012-02-10
- Days to decision
- 723 days
- Decision code
- APWD
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Vista, CA
- Statement
- APPROVAL FOR THE BREAST COMPANION SOFTWARE SYSTEM. THE BREAST COMPANION IS A COMPUTER-AIDED SYSTEM INTENDED FOR IMPROVING THE ACR BI-RADS ASSESSMENT OF ULTRASOUND IMAGES OF LESIONS OF THE FEMALE BREAST AS PART OF THE DIAGNOSTIC WORKSHOP.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BI-RADS COMPANION (K072258) | Almen Laboratories, Inc. | 2008-05-16 |