Brainomix 360 Triage LVO
FDA 510(k) K231837 · Brainomix Limited
510(k) numberK231837
Submission
- Device name
- Brainomix 360 Triage LVO
- Applicant
- Brainomix Limited
Oxford, GB - Received
- June 22, 2023
- Decision date
- September 28, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QAS – Radiological Computer-Assisted Triage And Notification Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2080
- Specialty
- Radiology
Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on…
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| 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 |
| K231656 | Brainomix 360 e-MRILLZ · Traditional | 08/30/2023SE |
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Questions and answers
When was Brainomix 360 Triage LVO cleared by the FDA?
Brainomix 360 Triage LVO (K231837) received a 510(k) decision of Substantially Equivalent on September 28, 2023, 98 days after the submission was received.
What is the product code of K231837?
The FDA product code is QAS – Radiological Computer-Assisted Triage And Notification Software, a Class II (moderate risk) device regulated under 21 CFR 892.2080.