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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 K250469
Device Name Accuro® 3S Needle Guide Kit
Applicant
Rivanna Medical, Inc.
2400 Hunters Way
Charlottesville,  VA  22911
Applicant Contact Will Mauldin
Correspondent
Rivanna Medical, Inc.
2400 Hunters Way
Charlottesville,  VA  22911
Correspondent Contact Will Mauldin
Regulation Number892.1570
Classification Product Code
ITX  
Date Received02/18/2025
Decision Date 06/13/2025
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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