510(k) clearances for Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
23 on file
- Koios Medical, Inc.Jul 2, 2026
K253884 · Koios DS (3.8)
- SonioJun 4, 2026
K261519 · Sonio Suspect
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLCMar 27, 2026
K254161 · Automated Aortic Stenosis Software (AutoAS)
- Precision Medical Ventures, Inc. Dba RevealdxJan 30, 2026
K251769 · RevealAI-Lung
- BrightheartDec 8, 2025
K252294 · Fetal EchoScan (v1.2)
- Circle Cardiovascular Imaging, Inc.Jul 1, 2025
K250221 · StrokeSENS ASPECTS Software Application
- BrightheartMay 2, 2025
K251071 · Fetal EchoScan (v1.1)
- SonioFeb 21, 2025
K243614 · Sonio Suspect
- Brainomix LimitedFeb 14, 2025
K243294 · Brainomix 360 e-ASPECTS
- Koios Medical, Inc.Nov 15, 2024
K242130 · Koios DS
- BrightheartNov 14, 2024
K242342 · Fetal EchoScan
- Echo IQ, Ltd.Oct 4, 2024
K241245 · EchoSolv AS
- AisapAug 1, 2024
K234141 · AISAP Cardio V1.0
- Avicenna.AiMar 15, 2024
K233342 · CINA-ASPECTS
- Ischemaview, Inc.Jan 19, 2024
K232156 · Rapid ASPECTS (v3)
- Brainomix LimitedFeb 23, 2023
K221564 · Brainomix 360 e-ASPECTS
- Avenda Health, Inc.Nov 22, 2022
K221624 · Avenda Health AI Prostate Cancer Planning Software
- Koios Medical, Inc.Dec 16, 2021
K212616 · Koios DS
- Optellum, Ltd.Mar 5, 2021
K202300 · Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
- Ultromics, Ltd.Dec 18, 2020
K201555 · EchoGo Pro
- Ischemaview, Inc.Jun 26, 2020
K200760 · Rapid ASPECTS
- Koios Medical, Inc.Jul 3, 2019
K190442 · Koios DS for Breast
- Quantitative Insights, Inc.Jul 19, 2017
DEN170022 · QuantX