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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)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
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?
| Field | syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc. | VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K260055 | K260597 |
| Device | syngo.CT Brain Quantification | VIRTUE QA |
| Applicant | Siemens Medical Solutions USA, Inc. | ProNova Solutions |
| Specialty / panel | Radiology | Radiology |
| Product code | QIH | LHN |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2026-01-08 | 2026-02-24 |
| Decision date | 2026-09-25 | 2026-09-23 |
| Review time (days) | 260 | 211 |
| Third-party review | No | No |
| Applicant location | Knoxville, TN, US | Maryville, TN, US |
| amount percentile | 82nd | 69th |
| Predicate Speed & CAPA Advisory Opportunity Score | 61/100 | 48/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
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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