Ligence Heart (K261733): 510(k) cleared for UAB Ligence
Ligence Heart (K261733): 510(k) cleared for UAB Ligence: 510(k) cleared for UAB Ligence. Its amount of 134 is below the median of 138 (49th percentile). Dated 28 days ago, it is in the active follow-up window. Score 36/100. 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: 134 · 49th percentile of 414 FDAPulse records · 1.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 0 related LT FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261733 |
| Device | Ligence Heart |
| Applicant | UAB Ligence |
| Specialty / panel | Radiology |
| Product code | QIH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-26 |
| Decision date | 2026-10-07 |
| Review time (days) | 134 |
| Third-party review | No |
| Applicant location | Kaunas, LT |
| amount percentile | 49th of 414 (median 138, 1.0x median) |
| Peer records CSV (1 LT records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-07
- Data refreshed: 2026-11-03
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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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36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 134-day review: this device is a strong predicate for similar products.
- Posted 28 days ago.
What is the FDAPulse record for Ligence Heart (K261733): 510(k) cleared for UAB Ligence?
Ligence Heart (K261733) by UAB Ligence was cleared on 2026-10-07 after 134 days of review.
How does Ligence Heart (K261733): 510(k) cleared for UAB Ligence compare to other FDAPulse records?
Its amount of 134 is below the median (49th percentile); smaller records often move faster and face less competition. It is 28 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Ligence Heart (K261733) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Ligence Heart (K261733) | LT | 2026-10-07 |
| VenusCT (K260510) | CA | 2026-10-19 |
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Radiology devices
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