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syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc. vs VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions: FDAPulse comparison

syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc.'s review days of 260 is 1.2x VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions's 211 (82nd percentile). syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc. is dated 2026-09-25; VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions 2026-09-23.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

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How does syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc. compare to VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions?

Fieldsyngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc.VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions
Record510(k) clearance510(k) clearance
510(k) numberK260055K260597
Devicesyngo.CT Brain QuantificationVIRTUE QA
ApplicantSiemens Medical Solutions USA, Inc.ProNova Solutions
Specialty / panelRadiologyRadiology
Product codeQIHLHN
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-01-082026-02-24
Decision date2026-09-252026-09-23
Review time (days)260211
Third-party reviewNoNo
Applicant locationKnoxville, TN, USMaryville, TN, US
amount percentile82nd69th
Predicate Speed & CAPA Advisory Opportunity Score61/10048/100
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Official records: syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc. · VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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