Company ยท US
Usa Instruments, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2005. Name variants (Inc, Corp, punctuation) are merged.
65510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 9, 2005 | K052916 | USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY Usa Instruments, Inc. | MOS |
| Oct 7, 2005 | K052621 | 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL Usa Instruments, Inc. | MOS |
| Oct 7, 2005 | K052584 | 1.5T 12 CHANNEL BODY ARRAY Usa Instruments, Inc. | MOS |
| Oct 4, 2005 | K052585 | 3T HD BREAST ARRAY Usa Instruments, Inc. | MOS |
| Jun 28, 2005 | K050728 | OPEN BREAST COIL (OBC) WITH BIOPSY PLATES Usa Instruments, Inc. | MOS |
| Sep 24, 2004 | K042342 | MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL Usa Instruments, Inc. | MOS |
| Aug 26, 2004 | K042207 | 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL Usa Instruments, Inc. | MOS |
| Aug 26, 2004 | K042186 | 3.0T 8-CHANNEL CTL SPINE ARRAY Usa Instruments, Inc. | MOS |
| Aug 11, 2004 | K042009 | MARK III PHASED ARRAY SHOULDER COIL Usa Instruments, Inc. | MOS |
| Jul 23, 2004 | K041695 | LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE Usa Instruments, Inc. | LNH |
| Jun 17, 2004 | K041487 | QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT Usa Instruments, Inc. | MOS |
| Jan 9, 2004 | K033490 | SPIRIT 5000 CARDIAC COIL Usa Instruments, Inc. | MOS |
| Dec 17, 2003 | K033753 | PELVIC ARRAY COIL Usa Instruments, Inc. | MOS |
| Dec 17, 2003 | K033235 | GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL Usa Instruments, Inc. | MOS |
| Nov 14, 2003 | K033353 | MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES Usa Instruments, Inc. | MOS |
| Sep 12, 2003 | K032618 | 3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL Usa Instruments, Inc. | MOS |
| Sep 12, 2003 | K032538 | 3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL Usa Instruments, Inc. | MOS |
| Aug 25, 2003 | K032474 | 3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL Usa Instruments, Inc. | MOS |
| Aug 25, 2003 | K032415 | MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL Usa Instruments, Inc. | MOS |
| Jul 30, 2003 | K031731 | MR FIBER OPTIC ECG GATING SYSTEM Sa Instruments, Inc. | LNH |
| Jul 18, 2003 | K031365 | PRIMA III TOTALSENSE TORSO COIL Usa Instruments, Inc. | MOS |
| Jul 11, 2003 | K031366 | PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. | MOS |
| May 29, 2003 | K031172 | SPIRIT III TOTALSENSE CARDIAC COIL Usa Instruments, Inc. | MOS |
| May 29, 2003 | K031143 | ALPHA 5000 WRIST COIL Usa Instruments, Inc. | MOS |
| May 29, 2003 | K031139 | PREMIER III PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. | MOS |
| May 8, 2003 | K031056 | MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. | MOS |
| May 5, 2003 | K030371 | PRIMA III TOTALSENSE TORSO COIL Usa Instruments, Inc. | MOS |
| Feb 24, 2003 | K030042 | PREMIER III PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. | MOS |
| Feb 21, 2003 | K023982 | LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE WRIST COIL Usa Instruments, Inc. | MOS |
| Feb 4, 2003 | K024187 | SPIRIT III TOTALSENSE CARDIAC COIL Usa Instruments, Inc. | MOS |
| Jan 24, 2003 | K023650 | INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL Usa Instruments, Inc. | MOS |
| Dec 23, 2002 | K023247 | CHAMPION 5000 PERIPHERAL VASCULAR COIL Usa Instruments, Inc. | MOS |
| Nov 4, 2002 | K022007 | LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES Usa Instruments, Inc. | MOS |
| Oct 22, 2002 | K022582 | EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL Usa Instruments, Inc. | MOS |
| Jul 25, 2002 | K021330 | MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL Usa Instruments, Inc. | MOS |
| Jun 27, 2002 | K021141 | MILLENNIUM 5000 MEUROVASCULAR COIL Usa Instruments, Inc. | MOS |
| May 21, 2002 | K021262 | MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL Usa Instruments, Inc. | MOS |
| Feb 6, 2002 | K013854 | MARK 5000 QUADRATURE SHOULDER COIL Usa Instruments, Inc. | MOS |
| Feb 5, 2002 | K014086 | CTL BODY / SPINE ARRAY COIL Usa Instruments, Inc. | MOS |
| Jan 22, 2002 | K013595 | PREMIER III PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. | MOS |
| Jan 22, 2002 | K013594 | BODY ARRAY COIL Usa Instruments, Inc. | MOS |
| Jan 8, 2002 | K013592 | EXTREMITY COIL Usa Instruments, Inc. | MOS |
| Dec 14, 2001 | K013541 | SHOULDER COIL Usa Instruments, Inc. | MOS |
| Dec 13, 2001 | K013528 | CRYSTAL 5000 PHASES ARRAY TMJ COIL Usa Instruments, Inc. | MOS |
| Dec 10, 2001 | K011683 | NURVO 9000 ENDOCAVITARY COILS Usa Instruments, Inc. | MOS |
| May 30, 2001 | K010946 | MARK 9000 PHASED ARRAY SHOULDER COIL Usa Instruments, Inc. | MOS |
| May 16, 2001 | K010730 | MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL Usa Instruments, Inc. | MOS |
| Oct 25, 2000 | K002483 | POWER 5000 GENERAL PURPOSE COIL Usa Instruments, Inc. | MOS |
| Oct 17, 2000 | K002482 | VISION 9000 PHASED ARRAY TORSO COIL Usa Instruments, Inc. | MOS |
| Aug 14, 2000 | K001870 | MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL Usa Instruments, Inc. | MOS |
Newest 50 of 65.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K041695 K052585 |
| 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 | K041695 K052585 |
| 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 | K041695 K052585 |
| 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 | K041695 K052585 |
| 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 | K041695 K052585 |
| Nov 9, 2006 | USA Instruments Incorporated 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System. Terminated |
MOS | K052916 |
| Nov 9, 2006 | USA Instruments Incorporated 1.5T HD Head Neck Spine Array, Model 2416329, for GE 1.5T Excite MR System. Terminated |
MOS | K052621 |
| Jul 20, 2004 | USA Instruments Inc. Prima III TotalSENSE Torso Coil (Body Array Coil), labeled as Manufactured by: USA Instruments, Inc. This device is a component of the Magnetom TRIO 3.0T MRI Systems, manufactured by Siemens AG Medic Terminated |
LNH | K030371 |