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FDA 510(k)

CINA-Aneurysm+

K-Number: K262147 · 2026-10-19

ApplicantAvicenna.Ai
Decision Date2026-10-19
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CINA-Aneurysm+ is the device name listed in this FDA 510(k) record. The listed applicant is Avicenna.Ai. It received FDA 510(k) clearance on 2026-10-19 under 510(k) number K262147. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CINA-Aneurysm+?

CINA-Aneurysm+ is a medical device that received FDA 510(k) clearance on 2026-10-19. The listed applicant is Avicenna.Ai. The 510(k) number is K262147.

When did CINA-Aneurysm+ receive FDA 510(k) clearance?

CINA-Aneurysm+ received FDA 510(k) clearance on 2026-10-19, under 510(k) number K262147.

Who is the listed applicant for CINA-Aneurysm+?

The FDA 510(k) record lists Avicenna.Ai as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CINA-Aneurysm+?

The FDA product code for CINA-Aneurysm+ is QIH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Avicenna.Ai as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262062CINA-AneurysmK240942CINA-CSpineK240612CINA-VCFK233342CINA-ASPECTSK233968CINA-iPEK221716CINA

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Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261733Ligence HeartUAB LigenceK262134NeuroDRDeep Reasoning Ai, Inc.K260523QGuideCT (1.0)Medis Medical Imaging Systems BVK260055syngo.CT Brain QuantificationSiemens Medical Solutions USA, Inc.K262390BoneXpertVisianaK261368Rapid Platform (R6.7)Ischemaview, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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