QAS · Radiological Computer-Assisted Triage And Notification Software

Device class

Class II

Regulation 892.2080

Total clearances

2020-03-18 → 2026-07-13

Last 12 months

Unique sponsors

Definition

What is Radiological Computer-Assisted Triage And Notification Software

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 .

Classification details

Medical specialty

Radiology

Review panel

Regulation number

892.2080

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Aidoc Medical , Ltd.	21	5	2026-05-14
Ischemaview, Inc.	9	2	2026-07-13
Ever Fortune.Ai, Co., Ltd.	5	1	2026-04-22
Avicenna.Ai	5	0	2024-09-12
Annalise-Ai Pty , Ltd.	4	0	2023-09-22
JLK, Inc.	4	1	2026-03-24
Viz. Ai, Inc.	4	0	2022-10-21
Brainomix Limited	4	0	2025-08-26
Siemens Medical Solutions USA, Inc.	3	0	2025-04-10
Methinks Software, S.L	2	0	2025-08-20
Qure.Ai Technologies	2	1	2025-09-08
Ischemaview Incorporated	1	0	2020-03-31
GuideAI Health	1	1	2026-06-18
Curacloud Corp.	1	0	2020-04-13
Maxq AL , Ltd.	1	0	2020-08-07
Circle Neurovascular Imaging, Inc.	1	0	2021-10-14
Mlhealth 360	1	1	2025-11-25
Shanghai United Imaging Intelligence Co., Ltd.	1	0	2024-09-24
Heuron Co., Ltd.	1	0	2024-05-15
Infervision Medical Technology Co., Ltd.	1	0	2021-08-12
Nines, Inc.	1	0	2020-04-21
Sk, Inc.	1	0	2024-07-01
Nico-Lab B.V.	1	0	2020-11-20
Harrison-AI Medical Pty, Ltd.	1	1	2026-03-03
Nicolab B.V.	1	0	2021-07-08

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
70550	CPT	—	Medium	CPT for cardiac CT with image processing and analysis software
99457	CPT	—	Low	CPT for remote monitoring with computer-assisted analysis

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-13	K261085	iSchemaview	Rapid Vessel Occlusion (Rapid VO)
2026-06-18	K260729	GuideAI Health	Vascular Assist Occlusion Triage (VAOT) (v1.0)
2026-05-14	K261317	Aidoc Medical , Ltd.	BriefCase-Triage
2026-04-22	K253163	Ever Fortune.Ai, Co., Ltd.	EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
2026-03-24	K252421	JLK, Inc.	JLK-NCCT
2026-03-03	K253818	Harrison-AI Medical Pty, Ltd.	Annalise Enterprise
2026-02-26	K253578	Aidoc Medical , Ltd.	BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device
2026-01-27	K251195	Aidoc Medical , Ltd.	BriefCase-Triage
2026-01-07	K252970	Aidoc Medical , Ltd.	BriefCase-Triage: CARE Multi-triage CT Body
2025-11-25	K250694	Mlhealth 360	Scaida BrainCT-ICH (v1.0)
2025-11-24	K252366	A2z Radiology Ai, Inc.	a2z-Unified-Triage
2025-11-06	K253265	Aidoc Medical , Ltd.	BriefCase-Triage
2025-09-08	K251610	Qure.Ai Technologies	qER-CTA (v1.0)
2025-09-04	K251533	Ischemaview, Inc.	Rapid Obstructive Hydrocephalus, Rapid OH
2025-08-26	K251983	Brainomix Limited	Brainomix 360 Triage Stroke
2025-08-20	K251590	Methinks Software, S.L	Methinks CTA Stroke
2025-07-16	K251151	Ischemaview	Rapid CTA 360
2025-06-16	K250685	Methinks Software, S.L	Methinks NCCT Stroke
2025-05-30	K251406	Aidoc Medical , Ltd.	BriefCase-Triage
2025-04-10	K243145	Siemens Medical Solutions USA, Inc.	syngo.CT LVO Detection
2025-03-03	K243611	JLK, Inc.	JLK-SDH
2025-02-20	K242821	Ever Fortune.Ai, Co., Ltd.	EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
2025-02-14	K250248	Aidoc Medical , Ltd.	BriefCase-Triage
2025-01-03	K243363	JLK, Inc.	JLK-ICH
2024-12-06	K241923	Ever Fortune.Ai, Co., Ltd.	EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)