510(k) K052585 ยท MOS Coil, Magnetic Resonance, Specialty
3T HD BREAST ARRAY
| Applicant | Usa Instruments, Inc., Aurora OH, US |
| Decision | Substantially Equivalent, Oct 4, 2005 |
| Received | Sep 20, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052585
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2007 | USA Instruments Incorporated LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral Biopsy plate is sent to customers in the following configurations: 1) The plate is purchased in sets of 5 as p Terminated |
LNH | None listed |
| Feb 15, 2007 | USA Instruments Incorporated The recalled product is the medial biopsy plate, part #2414342. The biopsy plate is labeled in part: Medial Biopsy Plate, part 2414342, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instrum Terminated |
LNH | None listed |
| Feb 15, 2007 | USA Instruments Incorporated The recalled product is the Lateral biopsy plate, part #2414346. The biopsy plate is labeled in part: Lateral Biopsy Plate, part 2414346, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instr Terminated |
LNH | None listed |
| Feb 15, 2007 | USA Instruments Incorporated The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate is labeled in part: Disposable Biopsy Plate, part U1-150131, For Use with the Liberty 9000 8-Channel Breast Coil, Terminated |
LNH | None listed |
| Feb 15, 2007 | USA Instruments Incorporated The recalled product is the Large grid biopsy plate, part #2414797. The biopsy plate is labeled in part: Large Grid Biopsy Plate, part 2414797, For Use with the Liberty 9000 8-Channel Breast Coil, USA Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.