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FDA 510(k)

Brainomix 360 e-ASPECTS

K-Number: K221564 · 2023-02-23

ApplicantBrainomix Limited
Decision Date2023-02-23
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Brainomix 360 e-ASPECTS is the device name listed in this FDA 510(k) record. The listed applicant is Brainomix Limited. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K221564. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Brainomix 360 e-ASPECTS?

Brainomix 360 e-ASPECTS is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Brainomix Limited. The 510(k) number is K221564.

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

Brainomix 360 e-ASPECTS received FDA 510(k) clearance on 2023-02-23, under 510(k) number K221564.

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

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-ASPECTS?

The FDA product code for Brainomix 360 e-ASPECTS is POK.

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

View all 13 devices →

Related Devices (Code: POK)

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.

K253884Koios DS (3.8)Koios Medical, Inc.K261519Sonio SuspectSonioK254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK251769RevealAI-LungPrecision Medical Ventures, Inc. Dba RevealdxK252294Fetal EchoScan (v1.2)BrightheartK250221StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging, 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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