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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K250328
Device Name UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
Applicant
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-Shi,  JP 324-8550
Applicant Contact Orlando Tadeo Jr.
Correspondent
Canon Medical Systems USA, Inc.
2441 Michelle Dr.
Tustin,  CA  92780
Correspondent Contact Yoshiaki Cook
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Codes
IYN   IYO  
Date Received02/05/2025
Decision Date 04/30/2025
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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