ODYSSEY LX, MODEL 211320— 510(k) K003437

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K003437 for ODYSSEY LX, MODEL 211320, Substantially Equivalent on 2001-02-02. Applicant: Philips Medical Systems (Cleveland), Inc..

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2000-11-06
Decision date: 2001-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.