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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 K191467
Device Name Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0
Canon Medical Systems Corporation
1385 Shimoishigami
otawara-shi,  JP 324-8550
Applicant Contact paul biggins
Canon Medical Systems USA, Inc.
2441 Michelle Drive
tustin,  CA  92780
Correspondent Contact orlando tadeo
Regulation Number892.1550
Classification Product Code
Subsequent Product Codes
Date Received06/03/2019
Decision Date 07/19/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No