RADspeed Pro
FDA 510(k) clearance K152244 · decided 2016-06-20
Clearance details
- K-number
- K152244
- Device name
- RADspeed Pro
- Applicant
- Shimadzu Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-08-10
- Decision date
- 2016-06-20
- Days to decision
- 315 days
- Clearance type
- Traditional
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Kyoto, JP
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANS recall (Z-2294-2026) | Shimadzu Medical Systems | 2026-06-02 |