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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 K173274
Device Name Ceevra Reveal 2.0
Applicant
Ceevra, Inc.
180 Sansome St., 2nd Floor
San Francisco,  CA  94194
Applicant Contact Russ Yoshinaka
Correspondent
RAC Medical LLC
368 San Carlos St.
San Francisco,  CA  94104
Correspondent Contact Rory A. Carrillo
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/12/2017
Decision Date 07/10/2018
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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