MRCAT Head & Neck

System, Planning, Radiation Therapy Treatment

Philips Oy

The following data is part of a premarket notification filed by Philips Oy with the FDA for Mrcat Head & Neck.

Pre-market Notification Details

Device IDK214081
510k NumberK214081
Device Name:MRCAT Head & Neck
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant Philips Oy Ayritie 4 Vantaa,  FI 01510
ContactJanne Marvola
CorrespondentAnne-Sophie Glantenay
Philips Oy Ayritie 4 Vantaa,  FI 01510
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-27
Decision Date2022-04-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838107311 K214081 000
00884838112742 K214081 000

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