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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K181834
Device Name Ultimax-i, DREX-UI80 (V1.60)
Applicant
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi,  JP 324-8550
Applicant Contact Paul Biggins
Correspondent
Canon Mecial Systems, U.S., Inc.
2441 Michelle Drive
Tustin,  CA  92780
Correspondent Contact Paul Biggins
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received07/10/2018
Decision Date 07/19/2018
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
Recalls CDRH Recalls
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