510(k) K854654— SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007

Substantially Equivalent for Some Indications

Philips Medical Systems, Inc.

Clearance details

Applicant: Philips Medical Systems, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1985-11-19
Decision date: 1987-08-19
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Santa Ana, CA, US

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.