Shimadzu Corp.: FDA clearances and approvals
Shimadzu Corp. has 58 FDA 510(k) clearances (first 1979, latest 2026), across 16 product codes in 2 review panels. Median 510(k) review time: 95 days. Since 2017 its median was 111 days, against 112 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 408 |
| 2015 | 1 | 197 |
| 2016 | 2 | 326 |
| 2017 | 0 | — |
| 2018 | 1 | 136 |
| 2019 | 2 | 22 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 111 |
| 2025 | 0 | — |
| 2026 | 1 | 264 |
Review time against the same product codes
Since 2017, Shimadzu Corp.'s cleared 510(k)s took a median 111 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 9 | 9 |
| KPR | System, X-Ray, Stationary | 8 | 8 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 6 | 6 |
| IZI | System, X-Ray, Angiographic | 6 | 6 |
| IZL | System, X-Ray, Mobile | 5 | 5 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 4 | 4 |
| JAK | System, X-Ray, Tomography, Computed | 4 | 4 |
| ITX | Transducer, Ultrasonic, Diagnostic | 3 | 3 |
| IZX | Collimator, Manual, Radiographic | 3 | 3 |
| IZW | Collimator, Automatic, Radiographic | 2 | 2 |
Plus 6 more product codes.
Review panels
- Radiology (56)
- Cardiovascular (1)
Most recent Shimadzu Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252099 | Trinias | OWB | 2026-03-24 | 264 |
| K233719 | FDR Visionary Suite | KPR | 2024-03-28 | 128 |
| K233722 | RADspeed Pro | KPR | 2024-02-23 | 94 |
| K191877 | FLUOROspeed | JAA | 2019-08-05 | 21 |
| K190373 | SonialVision G4 | JAA | 2019-03-15 | 24 |
| K173517 | RADspeed fit | KPR | 2018-03-30 | 136 |
| K152294 | FDR Visionary Suite | KPR | 2016-07-15 | 337 |
| K152244 | RADspeed Pro | KPR | 2016-06-20 | 315 |
| K142341 | X-RAY TV SYSTEM SONIALVISION G4 | JAA | 2015-03-06 | 197 |
| K131075 | X-RAY TV SYSTEM SONIAL VISION G4 | JAA | 2014-03-28 | 345 |
48 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shimadzu Corp..
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 Shimadzu Corp. have?
Shimadzu Corp. has 58 FDA 510(k) clearances (first 1979, latest 2026), across 16 product codes in 2 review panels.
How long does FDA take to clear Shimadzu Corp.'s 510(k)s?
The median time from FDA receipt to decision across Shimadzu Corp.'s cleared 510(k)s is 95 days. Since 2017: 111 days, versus 112 days for all cleared 510(k)s in the same product codes.
What devices does Shimadzu Corp. make?
Its most frequent FDA product codes are JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 9); KPR (System, X-Ray, Stationary, 8); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 6).
Has Shimadzu Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Shimadzu Corp. Related entities may recall under other names.
Next steps
- See all 58 Shimadzu Corp. clearances with predicates and recalls
- Run predicate analysis for product code JAA, Shimadzu Corp.'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.