Shimadzu Precision Instruments, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Shimadzu Precision Instruments, Inc.” (first 1980, latest 1994), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 54 days. 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 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | 8 | 8 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 3 | 3 |
| JAK | System, X-Ray, Tomography, Computed | 3 | 3 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 2 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
| KPS | System, Tomography, Computed, Emission | 1 | 1 |
| KXJ | Table, Radiologic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (22)
- Clinical Chemistry (1)
Most recent Shimadzu Precision Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940294 | SHIMADZU MOBILE X-RAY SYSTEMS | OXO | 1994-03-16 | 54 |
| K890913 | SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT | IYO | 1989-09-06 | 194 |
| K884598 | SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 | JAA | 1989-04-20 | 168 |
| K884477 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B | KPR | 1989-03-15 | 141 |
| K875378 | SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION | KPS | 1988-11-16 | 321 |
| K882311 | SHIMADZU LATERAL C-ARM MH-31 | JAA | 1988-09-14 | 103 |
| K881674 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC | JAK | 1988-09-02 | 137 |
| K881795 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K | IZO | 1988-07-01 | 65 |
| K874910 | SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200 | IZI | 1988-07-01 | 213 |
| K875370 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX | JAK | 1988-05-18 | 139 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shimadzu Precision Instruments, 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.
- Shimadzu Medical Systems (90 510(k)s)
- Shimadzu Corp. (58 510(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 Precision Instruments, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Shimadzu Precision Instruments, Inc.” (first 1980, latest 1994), across 11 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 Precision Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shimadzu Precision Instruments, Inc. is 54 days.
Which FDA product codes appear under Shimadzu Precision Instruments, Inc.?
The most frequent FDA product codes under this applicant name are IZI (System, X-Ray, Angiographic, 8); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 3); JAK (System, X-Ray, Tomography, Computed, 3).
Next steps
- See all 23 Shimadzu Precision Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IZI, Shimadzu Precision Instruments, 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.