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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 Doppler, Ultrasonic
510(k) Number K201972
Device Name Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1
Applicant
Canon Medical Systems Corporation
1385 Shimoishigami
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 Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/15/2020
Decision Date 10/08/2020
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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