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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Charged-Particle, Medical
510(k) Number K260597
Device Name VIRTUE QA
Applicant
ProNova Solutions
330 Pellissippi Pl.
Maryville,  TN  37804
Applicant Contact Amy Bellendir
Correspondent
ProNova Solutions
330 Pellissippi Pl.
Maryville,  TN  37804
Correspondent Contact Amy Bellendir
Regulation Number892.5050
Classification Product Code
LHN  
Date Received02/24/2026
Decision Date 09/23/2026
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		 Yes
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