Fujifilm Medical Systems U.S.A, Inc.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Fujifilm Medical Systems U.S.A, Inc.” (first 2005, latest 2018), plus 1 PMA decision, across 15 product codes in 3 review panels. Median 510(k) review time under this name: 85 days. Since 2017 the median was 190 days, against 109 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 |
|---|---|---|
| 2012 | 2 | 74 |
| 2013 | 2 | 84 |
| 2014 | 4 | 136 |
| 2015 | 4 | 112 |
| 2016 | 5 | 28 |
| 2017 | 9 | 134 |
| 2018 | 2 | 262 |
| 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, 510(k)s cleared under the name Fujifilm Medical Systems U.S.A, Inc. took a median 190 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 13 | 13 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 6 | 6 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 5 | 5 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 3 | 3 |
| IZL | System, X-Ray, Mobile | 2 | 2 |
| KGE | Forceps, Biopsy, Electric | 2 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| FDA | Enteroscope And Accessories | 1 | 1 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 1 | 1 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 1 | 1 |
Plus 5 more product codes.
Review panels
Most recent Fujifilm Medical Systems U.S.A, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171291 | FUJIFILM Bronchoscope Model EB-530P | EOQ | 2018-01-19 | 262 |
| K171207 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M | ODG | 2018-01-11 | 261 |
| K173132 | ASPIRE Cristalle | MUE | 2017-10-27 | 28 |
| K171463 | ASPIRE Bellus II | LLZ | 2017-09-29 | 134 |
| K152257 | Fujifilm Duodenoscope Model ED-530XT | FDT | 2017-07-21 | 711 |
| K163624 | Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) | MQB | 2017-06-30 | 190 |
| K162749 | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR | FDS | 2017-06-15 | 258 |
| K171096 | Fujifilm Diathermic Slitter (FlushKnife) | KGE | 2017-05-09 | 26 |
| K170858 | FDR AQRO (DR-XD 1000) | IZL | 2017-04-24 | 33 |
| K162287 | Synapse 3D Perfusion Analysis | LLZ | 2017-04-06 | 234 |
29 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P160031 | PMA | ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION | 2017-01-10 |
Recalls
37 product recalls in 27 recall events; 0 initiated in the last five years. Most recent: 2021-04-30.
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 Medical Systems U.S.A, Inc. (a text match, not an official crosswalk):
- G0279 — Diagnostic digital breast tomosynthesis, unilateral or bilateral (list separately in addition to 77065 or 77066) (via OTE)
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 Sonosite, Inc. (25 510(k)s)
- FUJIFILM Healthcare Americas Corporation (13 510(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 Medical Systems U.S.A, Inc.?
FDA lists 39 510(k) clearances under the applicant name “Fujifilm Medical Systems U.S.A, Inc.” (first 2005, latest 2018), plus 1 PMA decision, across 15 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 Medical Systems U.S.A, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fujifilm Medical Systems U.S.A, Inc. is 85 days. Since 2017: 190 days, versus 109 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Fujifilm Medical Systems U.S.A, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 13); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 6); FDF (Colonoscope And Accessories, Flexible/Rigid, 5).
Next steps
- See all 39 Fujifilm Medical Systems U.S.A, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Fujifilm Medical Systems U.S.A, 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.