HEARTNAVIGATOR RELEASE 1— 510(k) K111245

Substantially Equivalent

Philips Medical Systems Nederland B.V.

FDA 510(k) clearance K111245 for HEARTNAVIGATOR RELEASE 1, Substantially Equivalent on 2011-07-29. 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: 2011-05-03
Decision date: 2011-07-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bothell, WA, 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.