PodSKAN HF Diagnostic X-ray System— 510(k) K231761
Substantially EquivalentSkanray Technologies Limited
FDA 510(k) clearance K231761 for PodSKAN HF Diagnostic X-ray System, Substantially Equivalent on 2023-10-27. Applicant: Skanray Technologies Limited.
Clearance details
- Applicant
- Skanray Technologies Limited
- Product code
- Code KPR
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mysore, IN
Adverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.