3T HD BREAST ARRAY
FDA 510(k) clearance K052585 · decided 2005-10-04
Clearance details
- K-number
- K052585
- Device name
- 3T HD BREAST ARRAY
- Applicant
- Usa Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-20
- Decision date
- 2005-10-04
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Aurora, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral B recall (Z-0505-2007) | USA Instruments Incorporated | 2007-02-15 |
| The recalled product is the medial biopsy plate, part #2414342. The biopsy plate is labele recall (Z-0516-2007) | USA Instruments Incorporated | 2007-02-15 |
| The recalled product is the Lateral biopsy plate, part #2414346. The biopsy plate is label recall (Z-0517-2007) | USA Instruments Incorporated | 2007-02-15 |
| The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate is recall (Z-0518-2007) | USA Instruments Incorporated | 2007-02-15 |
| The recalled product is the Large grid biopsy plate, part #2414797. The biopsy plate is la recall (Z-0519-2007) | USA Instruments Incorporated | 2007-02-15 |