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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 K173224
Device Name SPIN-SWI
Applicant
Spintech, Inc.
30200 Telegraph Rd., Suite 140
Bingham Farms,  MI  48025
Applicant Contact Kay Fuller
Correspondent
Spintech, Inc.
30200 Telegraph Rd., Suite 140
Bingham Farms,  MI  48025
Correspondent Contact Kay Fuller
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LLZ  
Date Received10/03/2017
Decision Date 02/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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