FUJIFILM Sonosite, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “FUJIFILM Sonosite, Inc.” (first 2013, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 28 days. Since 2017 the median was 28 days, against 101 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 |
|---|---|---|
| 2013 | 3 | 34 |
| 2014 | 1 | 28 |
| 2015 | 2 | 23 |
| 2016 | 7 | 24 |
| 2017 | 1 | 27 |
| 2018 | 1 | 25 |
| 2019 | 2 | 48 |
| 2020 | 2 | 28 |
| 2021 | 1 | 26 |
| 2022 | 0 | — |
| 2023 | 1 | 28 |
| 2024 | 0 | — |
| 2025 | 3 | 32 |
| 2026 | 1 | 15 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name FUJIFILM Sonosite, Inc. took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 25 | 25 |
Review panels
- Radiology (25)
Most recent FUJIFILM Sonosite, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260595 | Sonosite iLOOK Ultrasound System | IYN | 2026-03-10 | 15 |
| K253448 | Sonosite MT Ultrasound System | IYN | 2025-11-03 | 32 |
| K251106 | Sonosite LX and Sonosite PX Ultrasound Systems | IYN | 2025-08-29 | 140 |
| K251830 | Sonosite LX Ultrasound System | IYN | 2025-07-10 | 27 |
| K233597 | Sonosite LX Ultrasound System | IYN | 2023-12-06 | 28 |
| K213763 | Sonosite PX Ultrasound System | IYN | 2021-12-27 | 26 |
| K202160 | Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System | IYN | 2020-09-01 | 29 |
| K200964 | Sonosite PX Ultrasound System | IYN | 2020-05-08 | 28 |
| K190476 | FUJIFILM Sonosite Vevo MD Imaging System | IYN | 2019-03-15 | 16 |
| K183235 | SonoSite SII Ultrasound System | IYN | 2019-02-07 | 79 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named FUJIFILM Sonosite, Inc..
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.
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 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 Sonosite, Inc.?
FDA lists 25 510(k) clearances under the applicant name “FUJIFILM Sonosite, Inc.” (first 2013, latest 2026), across 1 product code 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 Sonosite, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name FUJIFILM Sonosite, Inc. is 28 days. Since 2017: 28 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under FUJIFILM Sonosite, Inc.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 25).
Next steps
- See all 25 FUJIFILM Sonosite, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYN, FUJIFILM Sonosite, 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.