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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, Mobile
510(k) Number K191813
Device Name MobileDiagnost wDR 2.2
Applicant
Sedecal SA
C/Pelaya, 9 - 13 Pol. Ind. Rio De Janeiro
Algete,  ES 28110
Applicant Contact Maria Luisa Gomez De Aguero
Correspondent
Laura Green, LLC.
227 East 284th Street
Willowick,  OH  44095
Correspondent Contact Laura Green
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received07/05/2019
Decision Date 08/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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