QAS — Radiological Computer-Assisted Triage And Notification Software Class II
Classification Details
- Product Code
- QAS
- Device Class
- Class II
- Regulation Number
- 892.2080
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Definition
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 software-based image analysis but does not provide information from the image analysis other than triage and notification .
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260729 | guideai health | Vascular Assist Occlusion Triage (VAOT) (v1.0) | June 18, 2026 |
| K261317 | aidoc medical | BriefCase-Triage | May 14, 2026 |
| K253163 | ever fortune.ai, co | EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) | April 22, 2026 |
| K252421 | jlk | JLK-NCCT | March 24, 2026 |
| K253818 | harrison-ai medical pty | Annalise Enterprise | March 3, 2026 |
| K253578 | aidoc medical | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; L | February 26, 2026 |
| K251195 | aidoc medical | BriefCase-Triage | January 27, 2026 |
| K252970 | aidoc medical | BriefCase-Triage: CARE Multi-triage CT Body | January 7, 2026 |
| K250694 | mlhealth 360 | Scaida BrainCT-ICH (v1.0) | November 25, 2025 |
| K252366 | a2z radiology ai | a2z-Unified-Triage | November 24, 2025 |
| K253265 | aidoc medical | BriefCase-Triage | November 6, 2025 |
| K251610 | qure.ai technologies | qER-CTA (v1.0) | September 8, 2025 |
| K251533 | ischemaview | Rapid Obstructive Hydrocephalus, Rapid OH | September 4, 2025 |
| K251983 | brainomix limited | Brainomix 360 Triage Stroke | August 26, 2025 |
| K251590 | methinks software, s.l | Methinks CTA Stroke | August 20, 2025 |
| K251151 | ischemaview | Rapid CTA 360 | July 16, 2025 |
| K250685 | methinks software, s.l | Methinks NCCT Stroke | June 16, 2025 |
| K251406 | aidoc medical | BriefCase-Triage | May 30, 2025 |
| K243145 | siemens medical solutions usa | syngo.CT LVO Detection | April 10, 2025 |
| K243611 | jlk | JLK-SDH | March 3, 2025 |