Cleared Traditional

K262062 - CINA-Aneurysm

K262062 is an FDA 510(k) clearance for CINA-Aneurysm, manufactured by Avicenna.Ai. The device is a Class 2 Radiology device with product code QBS cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K262062 · Avicenna.Ai · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
124d
Days
Class 2
Risk

K262062 is an FDA 510(k) clearance for the CINA-Aneurysm. Classified as Radiological Computer Assisted Detection/diagnosis Software For Fracture (product code QBS), Class II - Special Controls.

Submitted by Avicenna.Ai (La Ciotat, FR). The FDA issued a Cleared decision on October 20, 2026 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2090 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K262062

510(k) Number K262062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2026
Decision Date October 20, 2026
Days to Decision 124 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 107d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

QBS Device Classification - Class 2, Special Controls

Product Code QBS Radiological Computer Assisted Detection/diagnosis Software For Fracture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2090
Definition A Radiological Computer Assisted Detection And Diagnostic Software For Suspected Fracture Is An Image Processing Device Intended To Aid In The Detection, Localization, And/or Characterization Of Fracture On Acquired Medical Images (e.g. Radiography, Mr, Ct). The Device Detects, Identifies And/or Characterizes Fracture Based On Features Or Information Extracted From Images, And May Provide Information About The Presence, Location, And/or Characteristics Of The Fracture To The User. Primary Diagnostic And Patient Management Decisions Are Made By The Clinical User.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
John J. Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QBS Radiological Computer Assisted Detection/diagnosis Software For Fracture

All 11
Devices cleared under the same product code (QBS) and FDA review panel - the closest regulatory comparables to K262062.
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K223491 · Ge Medical Systems, LLC · May 2023
K262062 · CINA-Aneurysm
Download PDF FDA Summary Avicenna.Ai