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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K190668
Device Name Encompass 15 Channel Head Coil, 3T
Applicant
Qfix
440 Church Rd.
Avondale,  PA  19311
Applicant Contact Alexandra Low Smythe
Correspondent
Qfix
440 Church Rd.
Avondale,  PA  19311
Correspondent Contact Alexandra Low Smythe
Regulation Number892.1000
Classification Product Code
MOS  
Date Received03/15/2019
Decision Date 09/09/2019
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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