Aletia Index — Assessment Listings

76 Technologies listed

✓ PCCP Authorized⬡ Autonomous Output🔬 Pipeline

AllGreen StatusAmber StatusRed Status

Tool	Regulatory Status	Risk	Lifecycle Signals
Brightheart K251456 BrightHeart View Classifier	510k	Lower	Reviewed Not reviewed Pending verification	View
PathAI, Inc. K243391 AISight Dx	510k	Lower	Reviewed Not reviewed Pending verification	View
Medtronic Minimed, Inc. K251032 MiniMed 780G insulin pump	510k	Lower	Reviewed Not reviewed Pending verification	View
Mendaera, Inc. K250524 Mendaera Guidance System	510k	Lower	Reviewed Not reviewed Pending verification	View
Therapixel K243679 MammoScreen® (4)	510k	Lower	Reviewed Not reviewed Pending verification	View
Appliedvr K251519 RelieVRx (Pico G3)	510k	Lower	Reviewed Not reviewed Pending verification	View
Therapixel K243685 MammoScreen BD	510k	Lower	Reviewed Not reviewed Pending verification	View
Medtronic Minimed, Inc. K251217 SmartGuard technology; Predictive Low Glucose technology	510k	Lower	Reviewed Not reviewed Pending verification	View
Velmeni, Inc. K250753 VELMENI for DENTISTS (V4D)	510k	Lower	Reviewed Not reviewed Pending verification	View
Springbok, Inc. (Dba Springbok Analytics) K251682 MuscleView 2.0	510k	Lower	Reviewed Not reviewed Pending verification	View
Apple, Inc. K250507 Hypertension Notification Feature (HTNF)	510k	Lower	Reviewed Not reviewed Pending verification	View
Diagnoly K251368 FETOLY	510k	Lower	Reviewed Not reviewed Pending verification	View
Beijing Infervision Healthcare Medical Technology Co., Ltd. K250237 InferOperate Suite	510k	Lower	Reviewed Not reviewed Pending verification	View
Abbott Ireland K252357 Glucose2	510k	Lower	Reviewed Not reviewed Pending verification	View
ResMed Corp K251657 Personalized Therapy Comfort Settings (PTCS)	510k	Lower	Reviewed Not reviewed Pending verification	View
Ceribell, Inc. K251936 Ceribell Delirium Monitor System	510k	Lower	Reviewed Not reviewed Pending verification	View
Ultrasight , Ltd. K251416 UltraSight Guidance	510k	Lower	Reviewed Not reviewed Pending verification	View
Ultrasight , Ltd. K252235 PVAD IQ Software	510k	Lower	Reviewed Not reviewed Pending verification	View
Diabeloop K251152 DBLG2	510k	Lower	Reviewed Not reviewed Pending verification	View
Updoc, Inc. K253281 UpDoc	510k	Lower	Reviewed Not reviewed Pending verification	View
AliveCor, Inc. K252589 Corvair Monza	510k	Lower	Reviewed Not reviewed Pending verification	View
Alphatec Spine, Inc. K252842 SafeOp 3: Neural Informatix System	510k	Lower	Reviewed Not reviewed Pending verification	View
Medtronic Minimed, Inc. K253585 SmartGuard technology; Predictive Low Glucose technology	510k	Lower	Reviewed Not reviewed Pending verification	View
Qure.Ai Technologies K251934 qXR-Detect	510k	Lower	Reviewed Not reviewed Pending verification	View
Ever Fortune.Ai, Co., Ltd. K251306 Seg Pro V3 (RT-300)	510k	Lower	Reviewed Not reviewed Pending verification	View

Showing 51–75 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.