GE Healthcare Coils (USA Instruments, Inc.)
Waukesha, WI, US
Ge Healthcare Coils (Usa Instruments, Inc.) appears in FDA device records in Waukesha, WI. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for GE Healthcare Coils (USA Instruments, Inc.) between 2009 and 2026. The busiest year on record is 2017, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2017 | 2 |
| 2018 | 2 |
| 2023 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253738 | 3.0T AIR 32CH HNA | MOS | Substantially Equivalent | |
| K223378 | 3.0T 16ch AIR AA | MOS | Substantially Equivalent | |
| K182504 | 3.0T Air MP M, 3.0T Air MP L | MOS | Substantially Equivalent | |
| K180666 | 48CH Head Coil | MOS | Substantially Equivalent | |
| K172695 | AIR Anterior Array, AIR Posterior Array | MOS | Substantially Equivalent | |
| K163205 | 48CH Head Coil | MOS | Substantially Equivalent | |
| K143389 | 3.0T GEM RT Open Array | MOS | Substantially Equivalent | |
| K123327 | 1.5T GEM RT OPEN ARRAY | MOS | Substantially Equivalent | |
| K122174 | PEDIATRIC POSITIONER PAD SET | KXH | Substantially Equivalent | |
| K103365 | DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A | MOS | Substantially Equivalent | |
| K101492 | 8 CHANNEL CARDIAC PHASED ARRAY COIL | MOS | Substantially Equivalent | |
| K093348 | 3.0T 16 CHANNEL HEAD NECK SPINE COIL | MOS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain