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FDA 510(k)

Brainomix 360 Hyperdensity

K-Number: K260406 · 2026-06-12

ApplicantBrainomix Limited
Decision Date2026-06-12
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Brainomix 360 Hyperdensity is the device name listed in this FDA 510(k) record. The listed applicant is Brainomix Limited. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K260406. 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 Brainomix 360 Hyperdensity?

Brainomix 360 Hyperdensity is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Brainomix Limited. The 510(k) number is K260406.

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

Brainomix 360 Hyperdensity received FDA 510(k) clearance on 2026-06-12, under 510(k) number K260406.

Who is the listed applicant for Brainomix 360 Hyperdensity?

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 Hyperdensity?

The FDA product code for Brainomix 360 Hyperdensity is QIH.

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.

K251983Brainomix 360 Triage StrokeK242411Brainomix 360 e-LungK243294Brainomix 360 e-ASPECTSK242123Brainomix 360 e-CTAK233875Brainomix 360 e-LungK232496Brainomix 360 Triage Stroke

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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.

K261349SwiftMRAirs Medical, Inc.K260192DIANAROPCA ApSK254096VELMENI for DENTISTS (V4D) 3DVelmeni, Inc.K261535Hi-D Imaging 4TAVRHi-D Imaging AGK260206SkeletonPlannerUPlanner B.V. - PresurgeoK260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., 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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