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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 Echo, Ultrasonic
510(k) Number K243937
Device Name Accuro 3S
Applicant
Rivanna Medical, Inc.
2400 Hunters Way
Charlottesville,  VA  22911
Applicant Contact F. William Mauldin
Correspondent
Rivanna Medical, Inc.
2400 Hunters Way
Charlottesville,  VA  22911
Correspondent Contact F. William Mauldin
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received12/20/2024
Decision Date 05/23/2025
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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