Brainomix 360 e-Lung
FDA 510(k) K242411 · Brainomix Limited
510(k) numberK242411
Submission
- Device name
- Brainomix 360 e-Lung
- Applicant
- Brainomix Limited
Oxford, GB - Received
- August 14, 2024
- Decision date
- February 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAK
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| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
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| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | Varian Medical Systems, Inc. | 06/04/2026SE |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional | Canon Medical Systems Corporation | 05/20/2026SE |
| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
| K253686 | True Definition DLJAK · Traditional | Ge Healthcare Japan Corporation | 03/23/2026SE |
| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 03/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
More from Siemens Medical Solutions USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260406 | Brainomix 360 HyperdensityQIH · Traditional | 06/12/2026SE |
| K251983 | Brainomix 360 Triage StrokeQAS · Traditional | 08/26/2025SE |
| K243294 | Brainomix 360 e-ASPECTSPOK · Traditional | 02/14/2025SE |
| K242123 | Brainomix 360 e-CTALLZ · Traditional | 01/06/2025SE |
| 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-Lung cleared by the FDA?
Brainomix 360 e-Lung (K242411) received a 510(k) decision of Substantially Equivalent on February 19, 2025, 189 days after the submission was received.
What is the product code of K242411?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.