Aletia Index — Assessment Listings

Showing 76 of 5,119 indexed · Browse all 5,119 →· 36 in pipeline

All devices✓ PCCP Authorized⬡ Autonomous Output🔬 Pipeline36

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Tool	Description	Regulatory Status	Risk	Last sync
Tyto Care , Ltd. ALT-004493 FDA	Tyto Insights for Rhonchi Detection	510k	—	Mar 2026	View
Axial Medical Printing Limited ALT-004552 FDA	Axial3D Insight	510k	—	Mar 2026	View
HeartFlow, Inc. ALT-004577 FDA	HeartFlow Analysis	510k	—	Mar 2026	View
Moon Surgical ALT-004580 FDA	Maestro System (REF100)	510k	—	Mar 2026	View
Imvaria, Inc. ALT-004625 FDA	Fibresolve (with PCCP)	510k	—	Mar 2026	View
Ceribell, Inc. ALT-004629 FDA	Ceribell Infant Seizure Detection Software	510k	—	Mar 2026	View
A2z Radiology Ai, Inc. ALT-004643 FDA	a2z-Unified-Triage	510k	—	Mar 2026	View
Apple, Inc. ALT-006038 FDA	Irregular Rhythm Notification Feature (IRNF)	510k	—	Mar 2026	View
23AndMe, Inc. ALT-006039 FDA	23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)	510k	—	Mar 2026	View
Hamamatsu Photonics K.K. ALT-006042 FDA	NanoZoomer S360MD Slide scanner system	510k	—	Mar 2026	View
Clew Medical , Ltd. ALT-006043 FDA	CLEWICU System	510k	—	Mar 2026	View
Mriguidance B.V. ALT-006044 FDA	BoneMRI	510k	—	Mar 2026	View
Camdiab , Ltd. ALT-006048 FDA	CamAPS FX	510k	—	Mar 2026	View
AliveCor, Inc. ALT-006050 FDA	Corvair	510k	—	Mar 2026	View
Natural Cycles Nordic AB ALT-006055 FDA	Natural Cycles	510k	—	Mar 2026	View
Mighty Oak Medical ALT-006056 FDA	Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)	510k	—	Mar 2026	View
Subtle Medical, Inc. ALT-006061 FDA	AiMIFY (1.x)	510k	—	Mar 2026	View
Overjet, Inc. ALT-006062 FDA	Overjet Charting Assist	510k	—	Mar 2026	View
Diagnoly ALT-006064 FDA	FETOLY-HEART	510k	—	Mar 2026	View
Apple, Inc. ALT-006065 FDA	Sleep Apnea Notification Feature (SANF)	510k	—	Mar 2026	View
Medtronic, Inc. ALT-006069 FDA	Affera Integrated Mapping System; Impedance Localization Patch Kit	510k	—	Mar 2026	View
Icad, Inc. ALT-006070 FDA	ProFound Detection (V4.0)	510k	—	Mar 2026	View
Springbok, Inc. (Dba Springbok Analytics) ALT-006118 FDA	MuscleView 2.0	510k	—	Mar 2026	View
Imvaria, Inc. ALT-006074 FDA	ScreenDx	510k	—	Mar 2026	View
Siemens Healthcare GmbH ALT-006083 FDA	syngo Dynamics (Version VA41D)	510k	—	Mar 2026	View