Aletia Index — Assessment Listings

76 Technologies listed

✓ PCCP Authorized⬡ Autonomous Output🔬 Pipeline

AllGreen StatusAmber StatusRed Status

Tool	Regulatory Status	Risk	Lifecycle Signals
Ge Medical Systems Israel, Functional Imaging K241350 Clarify DL	510k	Moderate	Reviewed Not reviewed Pending verification	View
Epitel, Inc. K231779 REMI AI Discrete Detection Module	510k	Moderate	Reviewed Not reviewed Pending verification	View
Anumana, Inc. K250652 ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)	510k	Moderate	Reviewed Not reviewed Pending verification	View
A2z Radiology Ai, Inc. K252366 a2z-Unified-Triage	510k	Moderate	Reviewed Not reviewed Pending verification	View
Therapixel K241561 MammoScreen BD	510k	Moderate	Reviewed Not reviewed Pending verification	View
Ceribell, Inc. K252070 Ceribell Infant Seizure Detection Software	510k	Moderate	Reviewed Not reviewed Pending verification	View
Csd Labs K252284 eMurmur Heart AI	510k	Moderate	Reviewed Not reviewed Pending verification	View
Artera, Inc. DEN240068 ArteraAI Prostate	510k	Moderate	Reviewed Not reviewed Pending verification	View
Clarius Mobile Health Corp. K250226 Clarius Median Nerve AI	510k	Moderate	Reviewed Not reviewed Pending verification	View
Clarius Mobile Health Corp. K243853 Clarius Prostate AI	510k	Moderate	Reviewed Not reviewed Pending verification	View
Epitel, Inc. K240408 REMI-AI Rapid Detection Module (REMI-AI RDM)	510k	Moderate	Reviewed Not reviewed Pending verification	View
Anumana, Inc. K232699 Low Ejection Fraction AI-ECG Algorithm	510k	Moderate	Reviewed Not reviewed Pending verification	View
Beacon Biosignals, Inc. K233438 SleepStageML	510k	Moderate	Reviewed Not reviewed Pending verification	View
Clarius Mobile Health Corp. K233955 Clarius OB AI	510k	Moderate	Reviewed Not reviewed Pending verification	View
Exo Imaging K240953 AI Platform 2.0 (AIP002)	510k	Moderate	Reviewed Not reviewed Pending verification	View
Caption Health, Inc. K243065 Cardiac Guidance	510k	Moderate	Reviewed Not reviewed Pending verification	View
Huntleigh Healthcare , Ltd. K241368 Sonicaid Team3	510k	Moderate	Reviewed Not reviewed Pending verification	View
Subtle Medical, Inc. K243250 SubtleHD (1.x)	510k	Moderate	Reviewed Not reviewed Pending verification	View
Deski K242807 HeartFocus (V.1.1.1)	510k	Moderate	Reviewed Not reviewed Pending verification	View
Tyto Care , Ltd. K243567 Tyto Insights for Rhonchi Detection	510k	Moderate	Reviewed Not reviewed Pending verification	View
Ceribell, Inc. K241589 Ceribell Seizure Detection Software	510k	Moderate	Reviewed Not reviewed Pending verification	View
Empatica S.R.L. K242737 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal	510k	Moderate	Reviewed Not reviewed Pending verification	View
Moon Surgical K250984 Maestro System (REF100)	510k	Moderate	Reviewed Not reviewed Pending verification	View
HeartFlow, Inc. K250902 HeartFlow Analysis	510k	Moderate	Reviewed Not reviewed Pending verification	View
Axial Medical Printing Limited K250369 Axial3D Insight	510k	Moderate	Reviewed Not reviewed Pending verification	View

Showing 1–25 of 76

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Tool	Use Case	Regulatory Status	Risk	Lifecycle Signals
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Structured Assessment

Documented review of regulatory posture, evidence claims, and post‑market oversight signals.

Evidence Signals

Summary of validation data, stability, and outcomes evidence—kept readable for clinicians.

Lifecycle Transparency

Indicators for change control, monitoring, and transparency practices across the product lifecycle.