Aletia Index — Assessment Listings

76 Technologies listed

✓ PCCP Authorized⬡ Autonomous Output🔬 Pipeline

AllGreen StatusAmber StatusRed Status

Tool	Regulatory Status	Risk	Lifecycle Signals
Imvaria, Inc. K252041 Fibresolve (with PCCP)	510k	Moderate	Reviewed Not reviewed Pending verification	View
Apple, Inc. K231173 Irregular Rhythm Notification Feature (IRNF)	510k	Lower	Reviewed Not reviewed Pending verification	View
23AndMe, Inc. K223597 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)	510k	Lower	Reviewed Not reviewed Pending verification	View
Hamamatsu Photonics K.K. K233027 NanoZoomer S360MD Slide scanner system	510k	Lower	Reviewed Not reviewed Pending verification	View
Clew Medical , Ltd. K233216 CLEWICU System	510k	Lower	Reviewed Not reviewed Pending verification	View
Mriguidance B.V. K233030 BoneMRI	510k	Lower	Reviewed Not reviewed Pending verification	View
Bay Labs, Inc. DEN190040 Caption Guidance	510k	Moderate	Reviewed Not reviewed Pending verification	View
Caption Health K201992 Caption Guidance	510k	Moderate	Reviewed Not reviewed Pending verification	View
Medtronic, Inc. K210484 LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System	510k	Moderate	Reviewed Not reviewed Pending verification	View
Tyto Care , Ltd. K240555 Tyto Insights for Crackles Detection	510k	Moderate	Reviewed Not reviewed Pending verification	View
Camdiab , Ltd. K232603 CamAPS FX	510k	Moderate	Reviewed Not reviewed Pending verification	View
AliveCor, Inc. K231010 Corvair	510k	Lower	Reviewed Not reviewed Pending verification	View
Natural Cycles Nordic AB K241006 Natural Cycles	510k	Lower	Reviewed Not reviewed Pending verification	View
Mighty Oak Medical K234009 Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)	510k	Lower	Reviewed Not reviewed Pending verification	View
Subtle Medical, Inc. K240290 AiMIFY (1.x)	510k	Lower	Reviewed Not reviewed Pending verification	View
Overjet, Inc. K241684 Overjet Charting Assist	510k	Lower	Reviewed Not reviewed Pending verification	View
Diagnoly K241380 FETOLY-HEART	510k	Lower	Reviewed Not reviewed Pending verification	View
Apple, Inc. K240929 Sleep Apnea Notification Feature (SANF)	510k	Lower	Reviewed Not reviewed Pending verification	View
Medtronic, Inc. K241828 Affera Integrated Mapping System; Impedance Localization Patch Kit	510k	Lower	Reviewed Not reviewed Pending verification	View
Icad, Inc. K240417 ProFound Detection (V4.0)	510k	Lower	Reviewed Not reviewed Pending verification	View
Imvaria, Inc. K241891 ScreenDx	510k	Lower	Reviewed Not reviewed Pending verification	View
Siemens Healthcare GmbH K242551 syngo Dynamics (Version VA41D)	510k	Lower	Reviewed Not reviewed Pending verification	View
Cognoa, Inc. K243558 Canvas Dx	510k	Lower	Reviewed Not reviewed Pending verification	View
Brightheart K243684 BrightHeart View Classifier	510k	Lower	Reviewed Not reviewed Pending verification	View
Tandem Diabetes Care, Inc. K250798 Control-IQ+ technology	510k	Moderate	Reviewed Not reviewed Pending verification	View

Showing 26–50 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.