MRCAT Brain

System, Planning, Radiation Therapy Treatment

Philips Medical Systems MR Finland

The following data is part of a premarket notification filed by Philips Medical Systems Mr Finland with the FDA for Mrcat Brain.

Pre-market Notification Details

Device IDK193109
510k NumberK193109
Device Name:MRCAT Brain
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant Philips Medical Systems MR Finland Ayritie 4 Vantaa,  FI 01510
ContactJanne Marvola
CorrespondentJanne Marvola
Philips Medical Systems MR Finland Ayritie 4 Vantaa,  FI 01510
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-08
Decision Date2020-01-24

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