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FDA 510(k)

Brainomix 360 Triage LVO

K-Number: K231837 · 2023-09-28

ApplicantBrainomix Limited
Decision Date2023-09-28
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Brainomix 360 Triage LVO is the device name listed in this FDA 510(k) record. The listed applicant is Brainomix Limited. It received FDA 510(k) clearance on 2023-09-28 under 510(k) number K231837. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Brainomix 360 Triage LVO?

Brainomix 360 Triage LVO is a medical device that received FDA 510(k) clearance on 2023-09-28. The listed applicant is Brainomix Limited. The 510(k) number is K231837.

When did Brainomix 360 Triage LVO receive FDA 510(k) clearance?

Brainomix 360 Triage LVO received FDA 510(k) clearance on 2023-09-28, under 510(k) number K231837.

Who is the listed applicant for Brainomix 360 Triage LVO?

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

What is the FDA product code for Brainomix 360 Triage LVO?

The FDA product code for Brainomix 360 Triage LVO is QAS.

Other records listing Brainomix Limited 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.

K260406Brainomix 360 HyperdensityK251983Brainomix 360 Triage StrokeK242411Brainomix 360 e-LungK243294Brainomix 360 e-ASPECTSK242123Brainomix 360 e-CTAK233875Brainomix 360 e-Lung

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Related Devices (Code: QAS)

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.

K261085Rapid Vessel Occlusion (Rapid VO)iSchemaviewK260729Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI HealthK261317BriefCase-TriageAidoc Medical , Ltd.K253163EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd.K252421JLK-NCCTJLK, Inc.K253818Annalise EnterpriseHarrison-AI Medical Pty, Ltd.

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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