VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions
VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions (Tennessee): 510(k) cleared for ProNova Solutions. Its amount of 211 is above the median of 138 (69th percentile). Dated 42 days ago, it serves as a historical benchmark. Score 48/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 211 · 69th percentile of 414 FDAPulse records · 1.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 8 related TN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260597 |
| Device | VIRTUE QA |
| Applicant | ProNova Solutions |
| Specialty / panel | Radiology |
| Product code | LHN |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-02-24 |
| Decision date | 2026-09-23 |
| Review time (days) | 211 |
| Third-party review | No |
| Applicant location | Maryville, TN, US |
| amount percentile | 69th of 414 (median 138, 1.5x median) |
| Peer records CSV (9 TN records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-23
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (TN first): syngo.CT Brain Quantification (K260055) · NEXUS® Hip Stem (K262473) · TeKBrace Knotless Anchor (K263352) · Class II recall Z-0138-2027 · Class II recall Z-0137-2027 · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions and 9 Tennessee peers
- Tennessee FDAPulse records like this one: 9
- VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions's amount: 69th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Tennessee peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 211-day review, longer than typical.
- Posted 42 days ago.
What is the FDAPulse record for VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions in Tennessee?
VIRTUE QA (K260597) by ProNova Solutions was cleared on 2026-09-23 after 211 days of review.
How does VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions compare to other Tennessee FDAPulse records?
Its amount of 211 sits in the upper half (69th percentile) of 414 records; the median is 138. It is 42 days old, still within a typical 45-day follow-up window.
VIRTUE QA (K260597) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| VIRTUE QA (K260597) | TN | 2026-09-23 |
| VenusCT (K260510) | CA | 2026-10-19 |
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
Compare VIRTUE QA (K260597) vs syngo.CT Brain Quantification (K260055) →
Related records
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