Fujifilm Corporation: FDA clearances and approvals
Fujifilm Corporation has 70 FDA 510(k) clearances (first 2018, latest 2026), across 22 product codes in 4 review panels. Median 510(k) review time: 128 days. Since 2017 its median was 128 days, against 118 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 7 | 67 |
| 2019 | 20 | 108 |
| 2020 | 6 | 62 |
| 2021 | 5 | 53 |
| 2022 | 6 | 133 |
| 2023 | 2 | 267 |
| 2024 | 3 | 32 |
| 2025 | 8 | 173 |
| 2026 | 13 | 156 |
Review time against the same product codes
Since 2017, Fujifilm Corporation's cleared 510(k)s took a median 128 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FDS | Gastroscope And Accessories, Flexible/Rigid | 15 | 15 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 6 | 6 |
| LLZ | System, Image Processing, Radiological | 6 | 6 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 5 | 5 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 5 | 5 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | 4 | 4 |
| FDA | Enteroscope And Accessories | 3 | 3 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 3 | 3 |
| JAK | System, X-Ray, Tomography, Computed | 3 | 3 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 3 | 3 |
Plus 12 more product codes.
Review panels
- Gastroenterology and Urology (40)
- Radiology (22)
- Ear, Nose and Throat (6)
- General and Plastic Surgery (2)
Most recent Fujifilm Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261229 | SCENARIA View Phase 6.0 | JAK | 2026-09-18 | 156 |
| K261283 | APERTO Lucent MRI System | LNH | 2026-09-16 | 152 |
| K253836 | FCT iStream Phase 2 | JAK | 2026-09-04 | 277 |
| K261170 | BA-004CC | ITX | 2026-08-12 | 125 |
| K260567 | EW10-EC02 Endoscopy Support Program | QNP | 2026-08-07 | 169 |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 | FET | 2026-07-02 | 27 |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | EOQ | 2026-06-16 | 264 |
| K254075 | Synapse Lung Nodule AI | OEB | 2026-05-27 | 160 |
| K254189 | Synapse 3D Base Tools (V7.2) | QIH | 2026-04-30 | 128 |
| K253862 | APERTO Lucent MRI System | LNH | 2026-04-06 | 124 |
60 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fujifilm Corporation.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Fujifilm Corporation's product codes (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)
Frequently asked questions
How many FDA 510(k) clearances does Fujifilm Corporation have?
Fujifilm Corporation has 70 FDA 510(k) clearances (first 2018, latest 2026), across 22 product codes in 4 review panels.
How long does FDA take to clear Fujifilm Corporation's 510(k)s?
The median time from FDA receipt to decision across Fujifilm Corporation's cleared 510(k)s is 128 days. Since 2017: 128 days, versus 118 days for all cleared 510(k)s in the same product codes.
What devices does Fujifilm Corporation make?
Its most frequent FDA product codes are FDS (Gastroscope And Accessories, Flexible/Rigid, 15); EOQ (Bronchoscope (Flexible Or Rigid), 6); LLZ (System, Image Processing, Radiological, 6).
Has Fujifilm Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Fujifilm Corporation. Related entities may recall under other names.
Next steps
- See all 70 Fujifilm Corporation clearances with predicates and recalls
- Run predicate analysis for product code FDS, Fujifilm Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.