K233722
- 510(k) number
- K233722
- Device name
- RADspeed Pro
- Applicant
- Shimadzu Corporation JP
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2024-02-23
- Date received
- 2023-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K233722.pdf
Official FDA record: K233722
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.