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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 K221796
Device Name Cyware 4H and Cysart 4H
Applicant
Abys Medical
40 Rue Chef De Baie
La Rochelle,  FR 17000
Applicant Contact Arnaud Destainville
Correspondent
Abys Medical
40 Rue Chef De Baie
La Rochelle,  FR 17000
Correspondent Contact Arnaud Destainville
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/21/2022
Decision Date 12/30/2022
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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