MRCAT Pelvis

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 Pelvis.

Pre-market Notification Details

Device IDK182888
510k NumberK182888
Device Name:MRCAT Pelvis
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-15
Decision Date2019-04-30

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