Fujifilm Medical System U.S.A., Inc.: FDA clearances and approvals
Fujifilm Medical System U.S.A., Inc. has 71 FDA 510(k) clearances (first 1988, latest 2017), plus 1 PMA decision, across 19 product codes in 3 review panels. Median 510(k) review time: 83 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 9 | 107 |
| 2013 | 3 | 102 |
| 2014 | 2 | 174 |
| 2015 | 3 | 240 |
| 2016 | 2 | 190 |
| 2017 | 1 | 119 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Fujifilm Medical System U.S.A., Inc.'s cleared 510(k)s took a median 119 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 19 | 19 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 10 | 10 |
| EAM | Screen, Intensifying, Radiographic | 7 | 7 |
| LMC | Camera, Multi Format, Radiological | 7 | 7 |
| IXK | System, Imaging, X-Ray, Electrostatic | 4 | 4 |
| IXW | Processor, Radiographic-Film, Automatic | 4 | 4 |
| KPR | System, X-Ray, Stationary | 3 | 3 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 3 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 2 | 2 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | 2 |
Plus 9 more product codes.
Review panels
Most recent Fujifilm Medical System U.S.A., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163675 | Processor VP-7000, Light Source BL-7000 | FET | 2017-04-25 | 119 |
| K153206 | Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 | FDS | 2016-03-03 | 119 |
| K151474 | Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) | KGE | 2016-02-18 | 262 |
| K152138 | FDR D-EVO GL Flat Panel Detector System | MQB | 2015-11-05 | 97 |
| K150221 | EPX-4440HD and EPX-4400HD with FICE | FET | 2015-10-01 | 244 |
| K142629 | EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes | FDS | 2015-05-14 | 240 |
| K142003 | FDR D-EVO II FLAT PANEL DETECTOR SYSTEM | MQB | 2014-10-21 | 90 |
| K133976 | FUJIFILM ENDOSCOPIC CO2 REGULATOR | FCX | 2014-09-09 | 257 |
| K132188 | MAMMOGRAPHY VIEWER SMV658 | LLZ | 2013-10-25 | 102 |
| K130542 | SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS | LLZ | 2013-06-14 | 105 |
61 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P050014 | PMA | FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS) | 2006-07-10 |
Recalls
openFDA lists no recalls under a recalling firm named Fujifilm Medical System U.S.A., Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances does Fujifilm Medical System U.S.A., Inc. have?
Fujifilm Medical System U.S.A., Inc. has 71 FDA 510(k) clearances (first 1988, latest 2017), plus 1 PMA decision, across 19 product codes in 3 review panels.
How long does FDA take to clear Fujifilm Medical System U.S.A., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Fujifilm Medical System U.S.A., Inc.'s cleared 510(k)s is 83 days.
What devices does Fujifilm Medical System U.S.A., Inc. make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 19); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 10); EAM (Screen, Intensifying, Radiographic, 7).
Has Fujifilm Medical System U.S.A., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Fujifilm Medical System U.S.A., Inc. Related entities may recall under other names.
Next steps
- See all 71 Fujifilm Medical System U.S.A., Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Fujifilm Medical System U.S.A., Inc.'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.