K984545

Substantially Equivalent

RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS

Applicant: Philips Medical Systems North America, Inc.
Product code: IZI
Advisory panel: Radiology
Date received: 1998-12-22
Decision date: 1999-02-25
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, 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.