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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K213637
Device Name JAZZ Solo sensor
Applicant
Jazz Imaging, LLC Dba Jazz Imaging
San Jose,  CA  95131
Applicant Contact Todd C Miller
Correspondent
W. Edward Johansen
1239 Stanford St., #205
Santa Monica,  CA  90404
Correspondent Contact Ed Johansen
Regulation Number872.1800
Classification Product Code
MUH  
Date Received11/18/2021
Decision Date 12/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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