PHILIPS INTEGRIS V3000 FILM— 510(k) K921101
Substantially EquivalentPhilips Medical Systems, Inc.
FDA 510(k) clearance K921101 for PHILIPS INTEGRIS V3000 FILM, Substantially Equivalent on 1992-05-15. Applicant: Philips Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems, Inc.
- Product code
- Code IZI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1600
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- 5680 Da Best, NL
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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.