FUJIFILM Healthcare Americas Corporation: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “FUJIFILM Healthcare Americas Corporation” (first 2023, latest 2026), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 168 days. Since 2017 the median was 168 days, against 119 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 |
|---|---|---|
| 2023 | 5 | 143 |
| 2024 | 5 | 171 |
| 2025 | 2 | 188 |
| 2026 | 1 | 27 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name FUJIFILM Healthcare Americas Corporation took a median 168 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FDA | Enteroscope And Accessories | 2 | 2 |
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 2 | 2 |
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 1 | 1 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
Review panels
Most recent FUJIFILM Healthcare Americas Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261713 | Synapse PACS (7.6.0) | QIH | 2026-06-18 | 27 |
| K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | FDA | 2025-09-26 | 161 |
| K243647 | Synapse PACS (7.5) | QIH | 2025-06-30 | 216 |
| K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | FDA | 2024-06-13 | 258 |
| K233629 | APERTO Lucent MRI System | LNH | 2024-05-10 | 179 |
| K233687 | ECHELON Synergy V10.0 | LNH | 2024-05-03 | 168 |
| K233583 | FCT iSTREAM Phase 1 | JAK | 2024-04-26 | 171 |
| K240075 | FUJIFILM Endoscope Model EB-710XT | EOQ | 2024-02-07 | 28 |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | ITX | 2023-12-13 | 189 |
| K231941 | ARIETTA x10 | IYN | 2023-11-20 | 143 |
3 earlier clearances. See the full list in Caduvo.
Recalls
24 product recalls in 14 recall events; 24 initiated in the last five years. Most recent: 2026-07-22.
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 Americas 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 Corporaton (6 510(k)s)
- Fujifilm Healthcare Corporation (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 Americas Corporation?
FDA lists 13 510(k) clearances under the applicant name “FUJIFILM Healthcare Americas Corporation” (first 2023, latest 2026), across 9 product codes in 3 review panels. 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 Americas Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name FUJIFILM Healthcare Americas Corporation is 168 days. Since 2017: 168 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under FUJIFILM Healthcare Americas Corporation?
The most frequent FDA product codes under this applicant name are FDA (Enteroscope And Accessories, 2); JAK (System, X-Ray, Tomography, Computed, 2); LNH (System, Nuclear Magnetic Resonance Imaging, 2).
Next steps
- See all 13 FUJIFILM Healthcare Americas Corporation clearances with predicates and recalls
- Run predicate analysis for product code FDA, FUJIFILM Healthcare Americas 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.