Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ge Healthcare Coils (Usa Instruments, Inc.) · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
100 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253738 | 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) | 2026-01-23 | 60 | 0 |
| K223378 | 3.0T 16ch AIR AA | Ge Healthcare Coils (Usa Instruments, Inc.) | 2023-01-03 | 57 | 0 |
| K182504 | 3.0T Air MP M, 3.0T Air MP L | Ge Healthcare Coils (Usa Instruments, Inc.) | 2018-10-12 | 30 | 0 |
| K180666 | 48CH Head Coil | Ge Healthcare Coils (Usa Instruments, Inc.) | 2018-04-12 | 29 | 0 |
| K172695 | AIR Anterior Array, AIR Posterior Array | Ge Healthcare Coils (Usa Instruments, Inc.) | 2017-11-22 | 76 | 0 |
| K163205 | 48CH Head Coil | Ge Healthcare Coils (Usa Instruments, Inc.) | 2017-01-12 | 58 | 0 |
| K143389 | 3.0T GEM RT Open Array | Ge Healthcare Coils (Usa Instruments, Inc.) | 2015-03-06 | 100 | 0 |
| K123327 | 1.5T GEM RT OPEN ARRAY | Ge Healthcare Coils (Usa Instruments, Inc.) | 2013-01-11 | 77 | 0 |
| K122174 | PEDIATRIC POSITIONER PAD SET | Ge Healthcare Coils (Usa Instruments, Inc.) | 2012-11-16 | 116 | 0 |
| K103365 | DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T | Ge Healthcare Coils (Usa Instruments, Inc.) | 2011-01-12 | 56 | 0 |
| K101492 | 8 CHANNEL CARDIAC PHASED ARRAY COIL | Ge Healthcare Coils (Usa Instruments, Inc.) | 2010-06-23 | 22 | 0 |
| K093348 | 3.0T 16 CHANNEL HEAD NECK SPINE COIL | Ge Healthcare Coils (Usa Instruments, Inc.) | 2009-11-25 | 29 | 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