510(k) K924082— PHILIPS TOMOSCAN SR7000 CT SYSTEMS

Substantially Equivalent

Philips Medical Systems, Inc.

Clearance details

Applicant: Philips Medical Systems, Inc.
Product code: Code JAK
Advisory panel: Radiology
Date received: 1992-08-13
Decision date: 1993-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 5680 Da Best, NL

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.