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FDA 510(k)

VIRTUE QA

K-Number: K260597 · 2026-09-23

ApplicantProNova Solutions
Decision Date2026-09-23
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VIRTUE QA is the device name listed in this FDA 510(k) record. The listed applicant is ProNova Solutions. It received FDA 510(k) clearance on 2026-09-23 under 510(k) number K260597. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRTUE QA?

VIRTUE QA is a medical device that received FDA 510(k) clearance on 2026-09-23. The listed applicant is ProNova Solutions. The 510(k) number is K260597.

When did VIRTUE QA receive FDA 510(k) clearance?

VIRTUE QA received FDA 510(k) clearance on 2026-09-23, under 510(k) number K260597.

Who is the listed applicant for VIRTUE QA?

The FDA 510(k) record lists ProNova Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIRTUE QA?

The FDA product code for VIRTUE QA is LHN.

Other records listing ProNova Solutions as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162246ProNova SC360 Proton Therapy System

Related Devices (Code: LHN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus Respiratory Motion Management SystemEmpnia, Inc.K242418P-Cure Proton Therapy System (PPTS)P-Cure, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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