Annalise Enterprise
FDA 510(k) K253818 · Harrison-AI Medical Pty, Ltd.
Submission
- Device name
- Annalise Enterprise
- Applicant
- Harrison-AI Medical Pty, Ltd.
Sydney, AU - Received
- November 28, 2025
- Decision date
- March 3, 2026
- 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…
Other 510(k)s with product code QAS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261085 | Rapid Vessel Occlusion (Rapid VO)QAS · Traditional | iSchemaview | 07/13/2026SE |
| 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 |
| 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 |
| K252366 | a2z-Unified-TriageQAS · Traditional | A2z Radiology Ai, Inc. | 11/24/2025SE |
Questions and answers
When was Annalise Enterprise cleared by the FDA?
Annalise Enterprise (K253818) received a 510(k) decision of Substantially Equivalent on March 3, 2026, 95 days after the submission was received.
What is the product code of K253818?
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.