MRI Planner

System, Planning, Radiation Therapy Treatment

Spectronic Medical AB

The following data is part of a premarket notification filed by Spectronic Medical Ab with the FDA for Mri Planner.

Pre-market Notification Details

Device IDK211841
510k NumberK211841
Device Name:MRI Planner
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant Spectronic Medical AB Karbingatan 36 Helsingborg,  SE 25467
ContactPer Bruhn
CorrespondentPer Bruhn
Spectronic Medical AB Karbingatan 36 Helsingborg,  SE 25467
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-14
Decision Date2022-08-25

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