ECHONAVIGATOR RELEASE 1— 510(k) K121781

Substantially Equivalent

Philips Medical Systems Nederland B.V.

FDA 510(k) clearance K121781 for ECHONAVIGATOR RELEASE 1, Substantially Equivalent on 2012-10-26. Applicant: Philips Medical Systems Nederland B.V..

Clearance details

Applicant: Philips Medical Systems Nederland B.V.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2012-06-18
Decision date: 2012-10-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Best Noord-Brabant, NL

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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.