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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasound Imaging For Vascular Access For Hemodialysis
510(k) Number K251673
Device Name X9 Ultrasound System
Applicant
X9, Inc.
10 Research Pkwy., Suite 350
Wallingford,  CT  06492
Applicant Contact Melissa Viotti
Correspondent
X9, Inc.
10 Research Pkwy., Suite 350
Wallingford,  CT  06492
Correspondent Contact Melissa Viotti
Regulation Number892.1560
Classification Product Code
SGH  
Subsequent Product Codes
ITX   IYO   QIH  
Date Received05/30/2025
Decision Date 10/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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