Brainomix 360 e-CTA
FDA 510(k) K242123 · Brainomix Limited
510(k) numberK242123
Submission
- Device name
- Brainomix 360 e-CTA
- Applicant
- Brainomix Limited
Oxford, GB - Received
- July 19, 2024
- Decision date
- January 6, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260588 | Cleerly LABSLLZ · Traditional | Cleerly, Inc. | 07/29/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | Boston Scientific Corporation | 07/24/2026SE |
| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
| K260500 | ResolutionMDLLZ · Traditional | ResolutionMD, Inc. | 07/21/2026SE |
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More from Avara Software
| 510(k) | Device | Decision |
|---|---|---|
| K260406 | Brainomix 360 HyperdensityQIH · Traditional | 06/12/2026SE |
| K251983 | Brainomix 360 Triage StrokeQAS · Traditional | 08/26/2025SE |
| K242411 | Brainomix 360 e-LungJAK · Traditional | 02/19/2025SE |
| K243294 | Brainomix 360 e-ASPECTSPOK · Traditional | 02/14/2025SE |
| K233875 | Brainomix 360 e-LungJAK · Traditional | 05/13/2024SE |
| K232496 | Brainomix 360 Triage StrokeQAS · Traditional | 11/21/2023SE |
| K231837 | Brainomix 360 Triage LVOQAS · Traditional | 09/28/2023SE |
| K231656 | Brainomix 360 e-MRILLZ · Traditional | 08/30/2023SE |
| K231195 | Brainomix 360 Triage ICHQAS · Traditional | 07/27/2023SE |
| K223555 | Brainomix 360 e-CTPLLZ · Traditional | 06/01/2023SE |
Questions and answers
When was Brainomix 360 e-CTA cleared by the FDA?
Brainomix 360 e-CTA (K242123) received a 510(k) decision of Substantially Equivalent on January 6, 2025, 171 days after the submission was received.
What is the product code of K242123?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.