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FDA 510(k)

Brainomix 360 e-CTP

K-Number: K223555 · 2023-06-01

ApplicantBrainomix Limited
Decision Date2023-06-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Brainomix 360 e-CTP is the device name listed in this FDA 510(k) record. The listed applicant is Brainomix Limited. It received FDA 510(k) clearance on 2023-06-01 under 510(k) number K223555. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Brainomix 360 e-CTP?

Brainomix 360 e-CTP is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Brainomix Limited. The 510(k) number is K223555.

When did Brainomix 360 e-CTP receive FDA 510(k) clearance?

Brainomix 360 e-CTP received FDA 510(k) clearance on 2023-06-01, under 510(k) number K223555.

Who is the listed applicant for Brainomix 360 e-CTP?

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 e-CTP?

The FDA product code for Brainomix 360 e-CTP is LLZ.

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: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, 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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