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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K171356
Device Name Clarity Reveal
Applicant
Ceevra, Inc.
3960 Franke Ln.
Lafayette,  CA  94549
Applicant Contact Russ Yoshinaka
Correspondent
Ceevra, Inc.
3960 Franke Ln.
Lafayette,  CA  94549
Correspondent Contact Russ Yoshinaka
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/09/2017
Decision Date 08/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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