510(k) K921101— PHILIPS INTEGRIS V3000 FILM

Substantially Equivalent

Philips Medical Systems, Inc.

Clearance details

Applicant: Philips Medical Systems, Inc.
Product code: Code IZI
Advisory panel: Radiology
Date received: 1992-03-09
Decision date: 1992-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 5680 Da Best, NL

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.