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FDA 510(k)

3D APT

K-Number: K172920 · 2018-01-22

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2018-01-22
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D APT 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 2018-01-22 under 510(k) number K172920. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D APT?

3D APT is a medical device that received FDA 510(k) clearance on 2018-01-22. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K172920.

When did 3D APT receive FDA 510(k) clearance?

3D APT received FDA 510(k) clearance on 2018-01-22, under 510(k) number K172920.

Who is the listed applicant for 3D APT?

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 3D APT?

The FDA product code for 3D APT is LNH.

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Official Source

View on FDA Database →

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

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