K231761
- 510(k) number
- K231761
- Device name
- PodSKAN HF Diagnostic X-ray System
- Applicant
- Skanray Technologies Limited IN
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2023-10-27
- Date received
- 2023-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K231761.pdf
Official FDA record: K231761
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.