Chrysalis Intelligence · Product Codes · QFM

QFM · Radiological Computer-Assisted Prioritization Software For Lesions

Radiology · 37 clearances · 25 unique sponsors

Device class
Class II
Regulation 892.2080
Total clearances
37
2020-02-28 → 2026-07-08
Last 12 months
3
Unique sponsors
25
Definition

What is Radiological Computer-Assisted Prioritization Software For Lesions

Radiological computer-assisted prioritization software for lesions 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.
Medical specialty
Radiology
Review panel
RA
Regulation number
892.2080
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Aidoc Medical , Ltd. 5 0 2024-12-11
Zebra Medical Vision, Ltd. 3 0 2021-12-15
Neurocareai, Inc. (Dba Savelife.Ai) 2 2 2026-07-08
Ever Fortune.Ai, Co., Ltd. 2 0 2022-11-08
Medcognetics, Inc. 2 1 2025-12-11
Annalise-Ai 2 0 2025-04-23
Viz. Ai, Inc. 2 0 2023-03-17
Annalise-Ai Pty , Ltd. 2 0 2023-03-28
Qure.Ai Technologies 1 0 2023-08-22
Vinbrain Joint Stock Company 1 0 2022-09-01
Shanghai United Imaging Intelligence Co., Ltd. 1 0 2021-01-15
Avicenna.Ai 1 0 2024-05-31
Riverain Technologies, Inc. 1 0 2022-03-10
Quanta Computer, Inc. 1 0 2023-01-27
Envisionit Deepai, Ltd. 1 0 2024-01-17
Lunit, Inc. 1 0 2021-11-10
Vuno, Inc. 1 0 2024-11-15
Milvue 1 0 2024-05-10
AZmed 1 0 2025-03-21
DeepHealth, Inc. 1 0 2021-04-16
Bering, Ltd. 1 0 2023-11-09
Vinbigdata Joint Stock Company 1 0 2024-05-23
Behold.Ai Technologies Limited 1 0 2020-02-28
Radlogics, Inc. 1 0 2020-04-08
Ischemaview, Inc. 1 0 2023-07-27
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.

CodeTypeDescriptionConfidenceRationale
76375 CPT Medium Multiplanar reformatting for prioritization of lesions
76376 CPT Medium 3D rendering of diagnostic images with prioritization/triage software
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-08 K253751 Neurocareai, Inc. (Dba Savelife.Ai) CXRDetectAI
2026-05-04 K252954 Neurocareai, Inc. (Dba Savelife.Ai) MammoSightAI
2025-12-11 K252482 Medcognetics, Inc. CogNet AI-MT+
2025-04-23 K250831 Annalise-Ai Annalise Enterprise
2025-03-21 K243808 AZmed Rayvolve PTX-PE
2024-12-11 K243548 Aidoc Medical , Ltd. BriefCase-Triage
2024-11-15 K241439 Vuno, Inc. VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
2024-05-31 K240612 Avicenna.Ai CINA-VCF
2024-05-23 K233108 Vinbigdata Joint Stock Company VinDr-Mammo
2024-05-10 K232410 Milvue SmartChest
2024-01-17 K231871 Envisionit Deepai, Ltd. Radify Triage
2023-11-09 K223754 Bering, Ltd. BraveCX
2023-08-22 K230899 Qure.Ai Technologies qXR-PTX-PE
2023-07-27 K230074 Ischemaview, Inc. Rapid Aneurysm Triage and Notification
2023-03-28 K222268 Annalise-Ai Pty , Ltd. Annalise Enterprise CXR Triage Trauma
2023-03-28 K222179 Annalise-Ai Pty , Ltd. Annalise Enterprise CXR Triage Trauma
2023-03-17 K223443 Viz. Ai, Inc. Viz AAA
2023-02-01 K230020 Aidoc Medical , Ltd. BriefCase
2023-01-27 K221868 Quanta Computer, Inc. QOCA image Smart CXR Image Processing System
2022-12-05 K222692 Aidoc Medical , Ltd. BriefCase
2022-11-08 K221552 Ever Fortune.Ai, Co., Ltd. EFAI ChestSuite XR Pneumothorax Assessment System
2022-09-29 K220080 Medcognetics, Inc. CogNet QmTRIAGE
2022-09-08 K222076 Ever Fortune.Ai, Co., Ltd. EFAI ChestSuite XR Pleural Effusion Assessment System
2022-09-01 K221241 Vinbrain Joint Stock Company DrAid for Radiology v1
2022-03-14 K214043 Aidoc Medical , Ltd. BriefCase