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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, planning, radiation therapy treatment
510(k) Number K211841
Device Name MRI Planner
Spectronic Medical AB
Karbingatan 36
Helsingborg,  SE 25467
Applicant Contact Per Bruhn
Spectronic Medical AB
Karbingatan 36
Helsingborg,  SE 25467
Correspondent Contact Per Bruhn
Regulation Number892.5050
Classification Product Code
Subsequent Product Code
Date Received06/14/2021
Decision Date 08/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No