Lung Nodule Assessment and Comparison Option (LNA)— 510(k) K162484

Substantially Equivalent

Philips Medical Systems Nederland B.V.

FDA 510(k) clearance K162484 for Lung Nodule Assessment and Comparison Option (LNA), Substantially Equivalent on 2017-02-23. 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: 2016-09-07
Decision date: 2017-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 5684 Pc Best, NL

Download summary PDF View on FDA.gov ↗

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.