Shimadzu Medical Systems: FDA clearances and approvals
Shimadzu Medical Systems has 90 FDA 510(k) clearances (first 1989, latest 2008), across 20 product codes in 2 review panels. Median 510(k) review time: 74 days. openFDA lists 26 product recalls by a recalling firm named Shimadzu Medical Systems.
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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 14 | 14 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 10 | 10 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 10 | 10 |
| IZI | System, X-Ray, Angiographic | 8 | 8 |
| IXR | Table, Radiographic, Tilting | 7 | 7 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 7 | 7 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 5 | 5 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 | 5 |
| ITX | Transducer, Ultrasonic, Diagnostic | 4 | 4 |
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 4 | 4 |
Plus 10 more product codes.
Review panels
- Radiology (89)
- Obstetrics and Gynecology (1)
Most recent Shimadzu Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082224 | DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC | ITX | 2008-12-15 | 131 |
| K071291 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 | ITX | 2008-01-09 | 246 |
| K071289 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | ITX | 2008-01-09 | 246 |
| K071287 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO | ITX | 2008-01-09 | 246 |
| K061643 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | IYN | 2006-07-27 | 45 |
| K061637 | ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO | IYN | 2006-07-25 | 43 |
| K061641 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO | IYO | 2006-07-14 | 32 |
| K052500 | DAR-8000F | IZI | 2005-10-17 | 34 |
| K052076 | DAR-8000I | IZI | 2005-09-02 | 32 |
| K050510 | ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 | IYN | 2005-04-01 | 31 |
80 earlier clearances. See the full list in Caduvo.
Recalls
26 product recalls in 16 recall events; 6 initiated in the last five years. Most recent: 2026-04-20.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Shimadzu Medical Systems's product codes (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Frequently asked questions
How many FDA 510(k) clearances does Shimadzu Medical Systems have?
Shimadzu Medical Systems has 90 FDA 510(k) clearances (first 1989, latest 2008), across 20 product codes in 2 review panels.
How long does FDA take to clear Shimadzu Medical Systems's 510(k)s?
The median time from FDA receipt to decision across Shimadzu Medical Systems's cleared 510(k)s is 74 days.
What devices does Shimadzu Medical Systems make?
Its most frequent FDA product codes are JAK (System, X-Ray, Tomography, Computed, 14); IZO (Generator, High-Voltage, X-Ray, Diagnostic, 10); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 10).
Has Shimadzu Medical Systems had device recalls?
openFDA lists 26 product recalls in 16 recall events by a recalling firm whose name matches Shimadzu Medical Systems; the most recent began 2026-04-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 90 Shimadzu Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code JAK, Shimadzu Medical Systems'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.