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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed echo, ultrasonic
510(k) Number K213254
Device Name Axialis Ophthalmic Ultrasound System
Applicant
Quantel Medical
11 Rue du Bois Joli-CS40015
Cournon D'Auvergne-Cedex,  FR 63808
Applicant Contact Bruno Pages
Correspondent
O'Connell Regulatory Consultants, Inc.
44 Oak Street
Stoneham,  MA  02180
Correspondent Contact Maureen O'Connell
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received09/30/2021
Decision Date 11/15/2021
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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