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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 K171778
Device Name MR Wireless Gating System, Model WGS-100
Applicant
Ivy Biomedical Systems, Inc.
11 Business Park Dr.
Branford,  CT  06405
Applicant Contact Nicole Bush
Correspondent
Ivy Biomedical Systems, Inc.
11 Business Park Dr.
Branford,  CT  06405
Correspondent Contact Nicole Bush
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/15/2017
Decision Date 03/14/2018
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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