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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K262474
Device Name ND Needle Guidance System
Applicant
Accurate Access, LLC
3951 E. Paradise View Dr.
Paradise Valley,  AZ  85253
Applicant Contact Nabil Dib
Correspondent
PRIA Healthcare Management, LLC
30 Batterson Park Rd.
Suite 120
Farmington,  CT  06032
Correspondent Contact Sam Murray
Regulation Number892.1570
Classification Product Code
ITX  
Date Received07/17/2026
Decision Date 07/27/2026
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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