Shimadzu Corp.: FDA filings under this applicant name
FDA lists 58 510(k) clearances under the applicant name “Shimadzu Corp.” (first 1979, latest 2026), across 16 product codes in 2 review panels. Median 510(k) review time under this name: 95 days. Since 2017 the median was 111 days, against 112 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.
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, 510(k)s cleared under the name Shimadzu Corp. 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 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.
- Shimadzu Medical Systems (90 510(k)s)
- Shimadzu Precision Instruments, Inc. (23 510(k)s)
- Shimadzu Corporation Medical Systems Division (2 510(k)s)
- Shimadzu Corporation Medical Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shimadzu Corp.?
FDA lists 58 510(k) clearances under the applicant name “Shimadzu Corp.” (first 1979, latest 2026), across 16 product codes in 2 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 Shimadzu Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shimadzu Corp. is 95 days. Since 2017: 111 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shimadzu Corp.?
The most frequent FDA product codes under this applicant name are JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 9); KPR (System, X-Ray, Stationary, 8); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 6).
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. 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.