PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2— 510(k) K031333
Substantially EquivalentPhilips Medical Systems North America, Inc.
FDA 510(k) clearance K031333 for PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2, Substantially Equivalent on 2003-05-13. Applicant: Philips Medical Systems North America, Inc..
Clearance details
- Applicant
- Philips Medical Systems North America, Inc.
- Product code
- Code IZI
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Da Best, NL
Adverse events under product code IZI
product code IZI- Death
- 9
- Malfunction
- 5,312
- Total
- 5,321
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.