Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FUJIFILM Sonosite, Inc. · Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
60 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260595 | Sonosite iLOOK Ultrasound System | FUJIFILM Sonosite, Inc. | 2026-03-10 | 15 | 0 |
| K253448 | Sonosite MT Ultrasound System | FUJIFILM Sonosite, Inc. | 2025-11-03 | 32 | 0 |
| K251106 | Sonosite LX and Sonosite PX Ultrasound Systems | FUJIFILM Sonosite, Inc. | 2025-08-29 | 140 | 0 |
| K251830 | Sonosite LX Ultrasound System | FUJIFILM Sonosite, Inc. | 2025-07-10 | 27 | 0 |
| K233597 | Sonosite LX Ultrasound System | FUJIFILM Sonosite, Inc. | 2023-12-06 | 28 | 0 |
| K213763 | Sonosite PX Ultrasound System | FUJIFILM Sonosite, Inc. | 2021-12-27 | 26 | 0 |
| K202160 | Sonosite PX Ultrasound System, Sonosite SII Ultrasound Syste | FUJIFILM Sonosite, Inc. | 2020-09-01 | 29 | 0 |
| K200964 | Sonosite PX Ultrasound System | FUJIFILM Sonosite, Inc. | 2020-05-08 | 28 | 0 |
| K190476 | FUJIFILM Sonosite Vevo MD Imaging System | FUJIFILM Sonosite, Inc. | 2019-03-15 | 16 | 0 |
| K183235 | SonoSite SII Ultrasound System | FUJIFILM Sonosite, Inc. | 2019-02-07 | 79 | 0 |
| K180704 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2018-04-13 | 25 | 0 |
| K171437 | SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2017-06-12 | 27 | 0 |
| K162288 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2016-09-08 | 24 | 0 |
| K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound | FUJIFILM Sonosite, Inc. | 2016-08-18 | 24 | 0 |
| K161119 | SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2016-05-13 | 23 | 0 |
| K160674 | Fujifilm Sonosite Vevo MD Imaging System | FUJIFILM Sonosite, Inc. | 2016-04-19 | 40 | 0 |
| K160734 | SonoSite SII Ultrasound System | FUJIFILM Sonosite, Inc. | 2016-04-05 | 19 | 0 |
| K160406 | FUJIFILM FC1 Ultrasound System | FUJIFILM Sonosite, Inc. | 2016-03-16 | 29 | 0 |
| K153626 | SonoSite Edge II Ultrasound System | FUJIFILM Sonosite, Inc. | 2016-01-20 | 33 | 0 |
| K152983 | FUJIFILM SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. | 2015-11-12 | 34 | 0 |
| K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2015-08-19 | 12 | 0 |
| K142017 | X-PORTE ULTRASOUND SYSTEM | FUJIFILM Sonosite, Inc. | 2014-08-22 | 28 | 0 |
| K133454 | SONOSITE EDGE ULTRASOUND SYSTEM | FUJIFILM Sonosite, Inc. | 2013-12-16 | 34 | 0 |
| K133134 | X-PORTE ULTRASOUND SYSTEM | FUJIFILM Sonosite, Inc. | 2013-11-04 | 34 | 0 |
| K130173 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | FUJIFILM Sonosite, Inc. | 2013-03-25 | 60 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda