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ProNova Solutions

FDA Regulatory Profile

ProNova Solutions has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Nov 15, 2023 · NAI
Latest 510(k)
Sep 23, 2026

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 15, 2023Maryville, TNDevicesNo Action Indicated (NAI)3010726836
Mar 12, 2020Maryville, TNDevicesNo Action Indicated (NAI)3010726836

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3010726836Maryville, TN2Nov 15, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K260597VIRTUE QASep 23, 2026
K162246ProNova SC360 Proton Therapy SystemDec 8, 2016

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.