ClearanceBrief
Company ยท GB

Brainomix Limited

FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2026. Name variants (Inc, Corp, punctuation) are merged.

13510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
LLZSystem, Image Processing, Radiological4
QASRadiological Computer-Assisted Triage And Notification Software4
JAKSystem, X-Ray, Tomography, Computed2
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer2
QIHAutomated Radiological Image Processing Software1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 12, 2026K260406Brainomix 360 Hyperdensity
Brainomix Limited, GB
QIH
Aug 26, 2025K251983Brainomix 360 Triage Stroke
Brainomix Limited, GB
QAS
Feb 19, 2025K242411Brainomix 360 e-Lung
Brainomix Limited, GB
JAK
Feb 14, 2025K243294Brainomix 360 e-ASPECTS
Brainomix Limited, GB
POK
Jan 6, 2025K242123Brainomix 360 e-CTA
Brainomix Limited, GB
LLZ
May 13, 2024K233875Brainomix 360 e-Lung
Brainomix Limited, GB
JAK
Nov 21, 2023K232496Brainomix 360 Triage Stroke
Brainomix Limited, GB
QAS
Sep 28, 2023K231837Brainomix 360 Triage LVO
Brainomix Limited, GB
QAS
Aug 30, 2023K231656Brainomix 360 e-MRI
Brainomix Limited, GB
LLZ
Jul 27, 2023K231195Brainomix 360 Triage ICH
Brainomix Limited, GB
QAS
Jun 1, 2023K223555Brainomix 360 e-CTP
Brainomix Limited, GB
LLZ
Feb 23, 2023K221564Brainomix 360 e-ASPECTS
Brainomix Limited, GB
POK
May 28, 2020K192692Brainomix 360 e-CTA
Brainomix Limited, GB
LLZ

Latest recalls

DateFirm and productCodeLinked 510(k)
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