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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K173749
Device Name AMRA Profiler
Applicant
AMRA Medical AB
Badhusgatan 5
Linkoping,  SE 58222
Applicant Contact Janne West
Correspondent
Licensale Inc
68 Southwood Ter
Southbury,  CT  06488
Correspondent Contact Raymond Kelly
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/08/2017
Decision Date 12/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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