Brainomix 360 Triage ICH
FDA 510(k) K231195 · Brainomix Limited
510(k) numberK231195
Submission
- Device name
- Brainomix 360 Triage ICH
- Applicant
- Brainomix Limited
Oxford, GB - Received
- April 27, 2023
- Decision date
- July 27, 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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| K251195 | BriefCase-TriageQAS · Traditional | Aidoc Medical , Ltd. | 01/27/2026SE |
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| 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 |
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| K223555 | Brainomix 360 e-CTPLLZ · Traditional | 06/01/2023SE |
Questions and answers
When was Brainomix 360 Triage ICH cleared by the FDA?
Brainomix 360 Triage ICH (K231195) received a 510(k) decision of Substantially Equivalent on July 27, 2023, 91 days after the submission was received.
What is the product code of K231195?
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.