Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Usa Instruments, Inc. — Predicate Candidate Screening
64 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
86 days90th percentile
64clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052916 | USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY | Usa Instruments, Inc. | 2005-11-09 | 23 | 1 |
| K052621 | 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL | Usa Instruments, Inc. | 2005-10-07 | 14 | 1 |
| K052584 | 1.5T 12 CHANNEL BODY ARRAY | Usa Instruments, Inc. | 2005-10-07 | 17 | 0 |
| K052585 | 3T HD BREAST ARRAY | Usa Instruments, Inc. | 2005-10-04 | 14 | 5 |
| K050728 | OPEN BREAST COIL (OBC) WITH BIOPSY PLATES | Usa Instruments, Inc. | 2005-06-28 | 99 | 0 |
| K042342 | MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL | Usa Instruments, Inc. | 2004-09-24 | 25 | 0 |
| K042207 | 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL | Usa Instruments, Inc. | 2004-08-26 | 10 | 0 |
| K042186 | 3.0T 8-CHANNEL CTL SPINE ARRAY | Usa Instruments, Inc. | 2004-08-26 | 14 | 0 |
| K042009 | MARK III PHASED ARRAY SHOULDER COIL | Usa Instruments, Inc. | 2004-08-11 | 16 | 0 |
| K041695 | LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE | Usa Instruments, Inc. | 2004-07-23 | 31 | 5 |
| K041487 | QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT | Usa Instruments, Inc. | 2004-06-17 | 13 | 0 |
| K033490 | SPIRIT 5000 CARDIAC COIL | Usa Instruments, Inc. | 2004-01-09 | 66 | 0 |
| K033753 | PELVIC ARRAY COIL | Usa Instruments, Inc. | 2003-12-17 | 16 | 0 |
| K033235 | GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL | Usa Instruments, Inc. | 2003-12-17 | 72 | 0 |
| K033353 | MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIO | Usa Instruments, Inc. | 2003-11-14 | 25 | 0 |
| K032618 | 3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL | Usa Instruments, Inc. | 2003-09-12 | 17 | 0 |
| K032538 | 3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL | Usa Instruments, Inc. | 2003-09-12 | 25 | 0 |
| K032415 | MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL | Usa Instruments, Inc. | 2003-08-25 | 20 | 0 |
| K032474 | 3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL | Usa Instruments, Inc. | 2003-08-25 | 13 | 0 |
| K031365 | PRIMA III TOTALSENSE TORSO COIL | Usa Instruments, Inc. | 2003-07-18 | 79 | 0 |
| K031366 | PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL | Usa Instruments, Inc. | 2003-07-11 | 72 | 0 |
| K031143 | ALPHA 5000 WRIST COIL | Usa Instruments, Inc. | 2003-05-29 | 49 | 0 |
| K031172 | SPIRIT III TOTALSENSE CARDIAC COIL | Usa Instruments, Inc. | 2003-05-29 | 45 | 0 |
| K031139 | PREMIER III PHASED ARRAY CTL SPINE COIL | Usa Instruments, Inc. | 2003-05-29 | 49 | 0 |
| K031056 | MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL | Usa Instruments, Inc. | 2003-05-08 | 35 | 0 |
| K030371 | PRIMA III TOTALSENSE TORSO COIL | Usa Instruments, Inc. | 2003-05-05 | 90 | 1 |
| K030042 | PREMIER III PHASED ARRAY CTL SPINE COIL | Usa Instruments, Inc. | 2003-02-24 | 49 | 0 |
| K023982 | LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATU | Usa Instruments, Inc. | 2003-02-21 | 81 | 0 |
| K024187 | SPIRIT III TOTALSENSE CARDIAC COIL | Usa Instruments, Inc. | 2003-02-04 | 47 | 0 |
| K023650 | INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL | Usa Instruments, Inc. | 2003-01-24 | 86 | 0 |
| K023247 | CHAMPION 5000 PERIPHERAL VASCULAR COIL | Usa Instruments, Inc. | 2002-12-23 | 84 | 0 |
| K022007 | LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES | Usa Instruments, Inc. | 2002-11-04 | 138 | 0 |
| K022582 | EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL | Usa Instruments, Inc. | 2002-10-22 | 78 | 0 |
| K021330 | MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL | Usa Instruments, Inc. | 2002-07-25 | 90 | 0 |
| K021141 | MILLENNIUM 5000 MEUROVASCULAR COIL | Usa Instruments, Inc. | 2002-06-27 | 79 | 0 |
| K021262 | MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL | Usa Instruments, Inc. | 2002-05-21 | 29 | 0 |
| K013854 | MARK 5000 QUADRATURE SHOULDER COIL | Usa Instruments, Inc. | 2002-02-06 | 78 | 0 |
| K014086 | CTL BODY / SPINE ARRAY COIL | Usa Instruments, Inc. | 2002-02-05 | 56 | 0 |
| K013594 | BODY ARRAY COIL | Usa Instruments, Inc. | 2002-01-22 | 84 | 0 |
| K013595 | PREMIER III PHASED ARRAY CTL SPINE COIL | Usa Instruments, Inc. | 2002-01-22 | 84 | 0 |
| K013592 | EXTREMITY COIL | Usa Instruments, Inc. | 2002-01-08 | 70 | 0 |
| K013541 | SHOULDER COIL | Usa Instruments, Inc. | 2001-12-14 | 51 | 0 |
| K013528 | CRYSTAL 5000 PHASES ARRAY TMJ COIL | Usa Instruments, Inc. | 2001-12-13 | 51 | 0 |
| K011683 | NURVO 9000 ENDOCAVITARY COILS | Usa Instruments, Inc. | 2001-12-10 | 194 | 0 |
| K010946 | MARK 9000 PHASED ARRAY SHOULDER COIL | Usa Instruments, Inc. | 2001-05-30 | 62 | 0 |
| K010730 | MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL | Usa Instruments, Inc. | 2001-05-16 | 65 | 0 |
| K002483 | POWER 5000 GENERAL PURPOSE COIL | Usa Instruments, Inc. | 2000-10-25 | 72 | 0 |
| K002482 | VISION 9000 PHASED ARRAY TORSO COIL | Usa Instruments, Inc. | 2000-10-17 | 64 | 0 |
| K001870 | MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL | Usa Instruments, Inc. | 2000-08-14 | 55 | 0 |
| K001582 | LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE | Usa Instruments, Inc. | 2000-07-17 | 56 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda