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 a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2018-01-22 under approval 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. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K172920.

When was 3D APT approved by the FDA?

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

What company makes 3D APT?

3D APT is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for 3D APT?

The FDA product code for 3D APT is LNH.

Other Devices by Philips Medical Systems Nederland B.V.

K162940MultiBand SENSE K162955Multi-Modality Tumor Tracking (MMTT) application K162859Allura Xper FD series and Allura Xper OR Table series K160455AneurysmFlow K160147CT TrueView K1618392D Quantitative Analysis

View all 77 devices →

Related Devices (Code: LNH)

K162940MultiBand SENSEPhilips Medical Systems Nederland B.V. K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc. K162403HyperBandGe Medical Systems, LLC K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc. K161973G-scan Brio, S-scanEsaote, S.p.A.

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.