ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES— 510(k) K141979
Substantially EquivalentPhilips Medical Systems Netherland BV
FDA 510(k) clearance K141979 for ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES, Substantially Equivalent on 2014-08-19. Applicant: Philips Medical Systems Netherland BV.
Clearance details
- Applicant
- Philips Medical Systems Netherland BV
- Product code
- Code OWB
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Best, NL
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.