CINA-Aneurysm (K262062): 510(k) cleared for Avicenna.Ai

CINA-Aneurysm (K262062): 510(k) cleared for Avicenna.Ai: 510(k) cleared for Avicenna.Ai. Its amount of 124 is below the median of 138 (46th percentile). Dated 15 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: 124 · 46th percentile of 414 FDAPulse records · 0.9x 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.

FieldValue
Record510(k) clearance
510(k) numberK262062
DeviceCINA-Aneurysm
ApplicantAvicenna.Ai
Specialty / panelRadiology
Product codeQBS
Device class2
Clearance typeTraditional
DecisionSubstantially Equivalent
Received2026-06-18
Decision date2026-10-20
Review time (days)124
Third-party reviewNo
Applicant locationLa Ciotat, FR
amount percentile46th of 414 (median 138, 0.9x median)
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  • Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
  • Record date: 2026-10-20
  • 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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Peer benchmark and outreach value: CINA-Aneurysm (K262062): 510(k) cleared for Avicenna.Ai and 6 FR peers

  • FR FDAPulse records like this one: 6
  • CINA-Aneurysm (K262062): 510(k) cleared for Avicenna.Ai's amount: 46th 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)

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36 / 100 Predicate Speed & CAPA Advisory Opportunity Score

  • Fast 124-day review: this device is a strong predicate for similar products.
  • Posted 15 days ago.

What is the FDAPulse record for CINA-Aneurysm (K262062): 510(k) cleared for Avicenna.Ai?

CINA-Aneurysm (K262062) by Avicenna.Ai was cleared on 2026-10-20 after 124 days of review.

How does CINA-Aneurysm (K262062): 510(k) cleared for Avicenna.Ai compare to other FDAPulse records?

Its amount of 124 is below the median (46th percentile); smaller records often move faster and face less competition. It is 15 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 (K262062) vs. top 3 peers

OrganizationLocationRecord date
CINA-Aneurysm (K262062)FR2026-10-20
VenusCT (K260510)CA2026-10-19
AVIEW Aorta Metrics (K260391)KR2026-10-16
Vista AI Scan (K260092)CA2026-10-07

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