Ge Healthcare Coils (Usa Instruments, Inc.): FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Ge Healthcare Coils (Usa Instruments, Inc.)” (first 2009, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 58 days. Since 2017 the median was 58 days, against 58 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under GE HealthCare, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 116 |
| 2013 | 1 | 77 |
| 2014 | 0 | — |
| 2015 | 1 | 100 |
| 2016 | 0 | — |
| 2017 | 2 | 67 |
| 2018 | 2 | 30 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 57 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 60 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ge Healthcare Coils (Usa Instruments, Inc.) took a median 58 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 58 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 11 | 11 |
| KXH | Cradle, Patient, Radiologic | 1 | 1 |
Review panels
- Radiology (12)
Most recent Ge Healthcare Coils (Usa Instruments, Inc.) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253738 | 3.0T AIR 32CH HNA | MOS | 2026-01-23 | 60 |
| K223378 | 3.0T 16ch AIR AA | MOS | 2023-01-03 | 57 |
| K182504 | 3.0T Air MP M, 3.0T Air MP L | MOS | 2018-10-12 | 30 |
| K180666 | 48CH Head Coil | MOS | 2018-04-12 | 29 |
| K172695 | AIR Anterior Array, AIR Posterior Array | MOS | 2017-11-22 | 76 |
| K163205 | 48CH Head Coil | MOS | 2017-01-12 | 58 |
| K143389 | 3.0T GEM RT Open Array | MOS | 2015-03-06 | 100 |
| K123327 | 1.5T GEM RT OPEN ARRAY | MOS | 2013-01-11 | 77 |
| K122174 | PEDIATRIC POSITIONER PAD SET | KXH | 2012-11-16 | 116 |
| K103365 | DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A | MOS | 2011-01-12 | 56 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ge Healthcare Coils (Usa Instruments, Inc.).
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Ge Healthcare Coils (Usa Instruments, Inc.) (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ge Healthcare Coils (Usa Instruments, Inc.)?
FDA lists 12 510(k) clearances under the applicant name “Ge Healthcare Coils (Usa Instruments, Inc.)” (first 2009, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ge Healthcare Coils (Usa Instruments, Inc.)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ge Healthcare Coils (Usa Instruments, Inc.) is 58 days. Since 2017: 58 days, versus 58 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ge Healthcare Coils (Usa Instruments, Inc.)?
The most frequent FDA product codes under this applicant name are MOS (Coil, Magnetic Resonance, Specialty, 11); KXH (Cradle, Patient, Radiologic, 1).
Next steps
- See all 12 Ge Healthcare Coils (Usa Instruments, Inc.) clearances with predicates and recalls
- Run predicate analysis for product code MOS, Ge Healthcare Coils (Usa Instruments, Inc.)'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.