CINA-Aneurysm+ (K262147): 510(k) cleared for Avicenna.Ai
CINA-Aneurysm+ (K262147): 510(k) cleared for Avicenna.Ai: 510(k) cleared for Avicenna.Ai. Its amount of 116 is below the median of 138 (42nd percentile). Dated 17 days ago, it is in the active follow-up window. Score 36/100. As of 2026-11-04, 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: 116 · 42th percentile of 414 FDAPulse records · 0.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 5 related FR FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262147 |
| Device | CINA-Aneurysm+ |
| Applicant | Avicenna.Ai |
| Specialty / panel | Radiology |
| Product code | QIH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-25 |
| Decision date | 2026-10-19 |
| Review time (days) | 116 |
| Third-party review | No |
| Applicant location | La Ciotat, FR |
| amount percentile | 42th of 414 (median 138, 0.8x median) |
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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: 2026-10-19
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (FR first): F.A.S.T Screw (K254280) · Yumizen H550 (K260781) · CINA-Aneurysm (K262062) · Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / · Alians Forearm (K262649) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: CINA-Aneurysm+ (K262147): 510(k) cleared for Avicenna.Ai and 6 FR peers
- FR FDAPulse records like this one: 6
- CINA-Aneurysm+ (K262147): 510(k) cleared for Avicenna.Ai's amount: 42nd percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every FR peer: $1,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 116-day review: this device is a strong predicate for similar products.
- Posted 17 days ago.
What is the FDAPulse record for CINA-Aneurysm+ (K262147): 510(k) cleared for Avicenna.Ai?
CINA-Aneurysm+ (K262147) by Avicenna.Ai was cleared on 2026-10-19 after 116 days of review.
How does CINA-Aneurysm+ (K262147): 510(k) cleared for Avicenna.Ai compare to other FDAPulse records?
Its amount of 116 is below the median (42th percentile); smaller records often move faster and face less competition. It is 17 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.
CINA-Aneurysm+ (K262147) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| CINA-Aneurysm+ (K262147) | FR | 2026-10-19 |
| 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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