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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, Fluoroscopic, Image-Intensified
510(k) Number K232526
Device Name XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
Applicant
Canon Medical Systems Corporation
1385 Shimoshigami
Otawara-Shi,  JP 324-8550
Applicant Contact Paul Biggins
Correspondent
Canon Medical Systems USA, Inc.
2441 Michelle Dr.
Tustin,  CA  92780
Correspondent Contact Orlando Tadeo
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
OWB  
Date Received08/21/2023
Decision Date 09/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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