ARTIS ULTRASOUND IMAGING SYSTEM— 510(k) K853565

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K853565 for ARTIS ULTRASOUND IMAGING SYSTEM, Substantially Equivalent on 1986-06-30. Applicant: Philips Medical Systems (Cleveland), Inc..

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1985-08-26
Decision date: 1986-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northford, CT, US

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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.