3D APT

System, Nuclear Magnetic Resonance Imaging

Philips Medical Systems Nederland B.V.

The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for 3d Apt.

Pre-market Notification Details

Device IDK172920
510k NumberK172920
Device Name:3D APT
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best,  NL 5684pc
ContactJan Van De Kerkhof
CorrespondentSusan Quick
Philips Medical Systems (Cleveland) Inc. 595 Miner Rd Cleveland,  OH  44143
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-25
Decision Date2018-01-22
Summary:summary

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