ProRad 2FC and ProRad 3NC Stationary Radiographic Systems— 510(k) K183541
Substantially EquivalentPrognosys Medical Systems Private Limited
FDA 510(k) clearance K183541 for ProRad 2FC and ProRad 3NC Stationary Radiographic Systems, Substantially Equivalent on 2019-01-24. Applicant: Prognosys Medical Systems Private Limited.
Clearance details
- Applicant
- Prognosys Medical Systems Private Limited
- Product code
- Code KPR
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bangalore, 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.