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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 K160185
Device Name Wrist 3
Applicant
Aspect Imaging, Ltd.
27 Shaked St.
Industrial Area Hevel Modi’In.,  IL 6085001
Applicant Contact ISRAEL CITRON
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MOS  
Date Received01/27/2016
Decision Date 03/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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