FDA.report

BRAINOMIX LIMITED

Matched from indexed company URL: Brainomix Limited

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30172101693017210169BRAINOMIX LIMITED1N2026-01-01First Floor, Seacourt tower West Way Oxford Oxfordshire GB OX2 0JJ

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2747171529803221K251983Brainomix 360 Triage StrokeQAS2025-08-26
2747171063070003K243294Brainomix 360 e-ASPECTSPOK2025-02-14
2747171941798913K242411Brainomix 360 e-LungJAK2025-02-19
2747171162076574K242123Brainomix 360 e-CTALLZ2025-01-06
2747171635476120K233875Brainomix 360 e-LungJAK2024-05-13
2747171654200378K232496Brainomix 360 Triage StrokeQAS2023-11-21
2747171524453407K231837Brainomix 360 Triage LVOQAS2023-09-28
2747171206146393K231656Brainomix 360 e-MRILLZ2023-08-30
2747171305655832K231195Brainomix 360 Triage ICHQAS2023-07-27
2747171328661067K223555Brainomix 360 e-CTPLLZ2023-06-01
2747171210187010K221564Brainomix 360 e-ASPECTSPOK2023-02-23
2747171294910605K192692Brainomix 360 e-CTALLZ2020-05-28

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
QAS42025-08-26
LLZ42025-01-06
JAK22025-02-19
POK22025-02-14

PMN

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