Annalise Enterprise CTB Triage-OH
FDA 510(k) K231094 · Annalise-Ai Pty , Ltd.
Submission
- Device name
- Annalise Enterprise CTB Triage-OH
- Applicant
- Annalise-Ai Pty , Ltd.
Sydney, AU - Received
- April 18, 2023
- Decision date
- August 15, 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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| K260729 | Vascular Assist Occlusion Triage (VAOT) (v1.0)QAS · Traditional | GuideAI Health | 06/18/2026SE |
| K261317 | BriefCase-TriageQAS · Special | Aidoc Medical , Ltd. | 05/14/2026SE |
| K253163 | Efai Ersuite CT Appendicitis Assessment System (APPEN-CT-100)QAS · Traditional | Ever Fortune.Ai, Co., Ltd. | 04/22/2026SE |
| K252421 | Jlk-NcctQAS · Traditional | JLK, Inc. | 03/24/2026SE |
| K253818 | Annalise EnterpriseQAS · Traditional | Harrison-AI Medical Pty, Ltd. | 03/03/2026SE |
| K253578 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large…QAS · Traditional | Aidoc Medical , Ltd. | 02/26/2026SE |
| K251195 | BriefCase-TriageQAS · Traditional | Aidoc Medical , Ltd. | 01/27/2026SE |
| K252970 | BriefCase-Triage: CARE Multi-triage CT BodyQAS · Traditional | Aidoc Medical , Ltd. | 01/07/2026SE |
| K250694 | Scaida BrainCT-ICH (v1.0)QAS · Traditional | Mlhealth 360 | 11/25/2025SE |
More from Mlhealth 360
| 510(k) | Device | Decision |
|---|---|---|
| K250831 | Annalise EnterpriseQFM · Special | 04/23/2025SE |
| K231767 | Annalise Enterprise CTB Triage TraumaQAS · Traditional | 09/22/2023SE |
| K231384 | Annalise Enterprise CTB Triage TraumaQAS · Traditional | 09/22/2023SE |
| K223240 | Annalise Enterprise CTB Triage TraumaQAS · Traditional | 04/03/2023SE |
| K222268 | Annalise Enterprise CXR Triage TraumaQFM · Traditional | 03/28/2023SE |
| K222179 | Annalise Enterprise CXR Triage TraumaQFM · Traditional | 03/28/2023SE |
| K213941 | Annalise Enterprise CXR Triage PneumothoraxQFM · Traditional | 02/24/2022SE |
Questions and answers
When was Annalise Enterprise CTB Triage-OH cleared by the FDA?
Annalise Enterprise CTB Triage-OH (K231094) received a 510(k) decision of Substantially Equivalent on August 15, 2023, 119 days after the submission was received.
What is the product code of K231094?
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.