Digiscan FDX— 510(k) K200218
Substantially EquivalentAllengers Medical Systems Limited
FDA 510(k) clearance K200218 for Digiscan FDX, Substantially Equivalent on 2020-07-13. Applicant: Allengers Medical Systems Limited.
Clearance details
- Applicant
- Allengers Medical Systems Limited
- Product code
- Code OWB
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Derabassi, Distt Mohali, IN
Adverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
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.