Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4

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 Ingenia 1.5t, Ingenia 1 5t S, Ingenia 1.5t Cx, Ingenia 3.0t Cx R5.4.

Pre-market Notification Details

Device IDK173079
510k NumberK173079
Device Name:Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best,  NL 5684pc
ContactJan Van De Kerkhot
CorrespondentSusan Quick
Philips Medical Systems (Cleveland) Inc 595 Miner Road Cleveland,  OH  44143
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2018-04-04
Summary:summary

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