Fujifilm Healthcare Corporation: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Fujifilm Healthcare Corporation” (first 2022, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 126 days. Since 2017 the median was 126 days, against 107 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 Fujifilm Healthcare, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 2 | 126 |
| 2023 | 2 | 239 |
| 2024 | 2 | 64 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fujifilm Healthcare Corporation took a median 126 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 4 | 4 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
Review panels
- Radiology (6)
Most recent Fujifilm Healthcare Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241429 | ECHELON Synergy MRI System | LNH | 2024-08-13 | 84 |
| K240571 | OASIS MRI System | LNH | 2024-04-12 | 43 |
| K223426 | ECHELON Synergy MRI system | LNH | 2023-07-13 | 241 |
| K221619 | ECHELON Oval V6.2 MRI System | LNH | 2023-01-26 | 237 |
| K213829 | SCENARIA View | JAK | 2022-05-23 | 166 |
| K220295 | ARIETTA 50 | IYN | 2022-04-29 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Fujifilm Healthcare Corporation.
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 Fujifilm Healthcare Corporation (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Fujifilm Medical System U.S.A., Inc. (71 510(k)s)
- Fujifilm Corporation (70 510(k)s)
- Fujifilm Medical Systems U.S.A, Inc. (39 510(k)s)
- FUJIFILM Sonosite, Inc. (25 510(k)s)
- FUJIFILM Healthcare Americas Corporation (13 510(k)s)
- Fujifilm Corporaton (6 510(k)s)
- Fujifilm Irvine Scientific (5 510(k)s)
- Fujifilm New Development U.S.A., Inc. (3 510(k)s)
- Fujifilm Medwork GmbH (2 510(k)s)
- Fujifilm Meidcal Systems U.S.A.,Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fujifilm Healthcare Corporation?
FDA lists 6 510(k) clearances under the applicant name “Fujifilm Healthcare Corporation” (first 2022, latest 2024), across 3 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 Fujifilm Healthcare Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fujifilm Healthcare Corporation is 126 days. Since 2017: 126 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Fujifilm Healthcare Corporation?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 4); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 1); JAK (System, X-Ray, Tomography, Computed, 1).
Next steps
- See all 6 Fujifilm Healthcare Corporation clearances with predicates and recalls
- Run predicate analysis for product code LNH, Fujifilm Healthcare Corporation'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.