FDA 510(k)

Lung Nodule Assessment and Comparison Option (LNA)

K-Number: K162484 · 2017-02-23

ApplicantPhilips Medical Systems Nederland B.V.

Decision Date2017-02-23

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Lung Nodule Assessment and Comparison Option (LNA) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K162484. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lung Nodule Assessment and Comparison Option (LNA)?

Lung Nodule Assessment and Comparison Option (LNA) is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K162484.

When did Lung Nodule Assessment and Comparison Option (LNA) receive FDA 510(k) clearance?

Lung Nodule Assessment and Comparison Option (LNA) received FDA 510(k) clearance on 2017-02-23, under 510(k) number K162484.

Who is the listed applicant for Lung Nodule Assessment and Comparison Option (LNA)?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lung Nodule Assessment and Comparison Option (LNA)?

The FDA product code for Lung Nodule Assessment and Comparison Option (LNA) is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.