510(k) Report

Devices descending from DEN170022

22 later devices reach QuantX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221624Avenda Health AI Prostate Cancer Planning SoftwareAvenda Health, Inc.20220—
+1K202300Optellum Virtual Nodule Clinic, Optellum software, Optellum platformOptellum, Ltd.20211—
+1K200760Rapid ASPECTSIschemaview, Inc.20205—
+1K190442Koios DS for BreastKoios Medical, Inc.201912—
+2K251769RevealAI-LungPrecision Medical Ventures, Inc. Dba Revealdx20260—
+2K233342Cina-AspectsAvicenna.Ai20240—
+2K232156Rapid ASPECTS (v3)Ischemaview, Inc.20240—
+2K221564Brainomix 360 e-ASPECTSBrainomix Limited20232—
+2K212616Koios DSKoios Medical, Inc.20214—
+2K201555EchoGo ProUltromics, Ltd.20206—
+3K254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+3K250221StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+3K243614Sonio SuspectSonio20251—
+3K243294Brainomix 360 e-ASPECTSBrainomix Limited20250—
+3K242130Koios DSKoios Medical, Inc.20241—
+3K242342Fetal EchoScanBrightheart20242—
+3K241245EchoSolv ASEcho IQ, Ltd.20240—
+3K234141AISAP Cardio V1.0Aisap20240—
+4K253884Koios DS (3.8)Koios Medical, Inc.20260—
+4K261519Sonio SuspectSonio20260—
+4K252294Fetal EchoScan (v1.2)Brightheart20250—
+4K251071Fetal EchoScan (v1.1)Brightheart20251—