Aletia Index — Assessment Listings

Showing 53 of 1,267 indexed · Browse all 1,267 →· 27 in pipeline

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Tool	Description	Regulatory Status	Risk	Last sync
Clarius Prostate AI Clarius Mobile Health Corp. · ALT-001083 FDA	Clarius Prostate AI	510k	—	Mar 2026	View
Caption Guidance Bay Labs, Inc. · ALT-001183 FDA	Caption Guidance	De Novo	—	Mar 2026	View
Overjet Charting Assist Overjet, Inc · ALT-006522 FDA	—	510k	—	Jun 2026	View
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System Medtronic, Inc. · ALT-001034 FDA	LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System	510k	—	Mar 2026	View
Caption Interpretation Automated Ejection Fraction Software Caption Health, Inc · ALT-006691 FDA	—	De Novo	—	Jun 2026	View
Tyto Insights for Crackles Detection Tyto Care , Ltd. · ALT-004324 FDA	Tyto Insights for Crackles Detection	510k	—	Mar 2026	View
MammoScreen BD Therapixel · ALT-004385 FDA	MammoScreen BD	510k	—	Mar 2026	View
Maestro System (REF100) Moon Surgical · ALT-004420 FDA	Maestro System (REF100)	510k	—	Mar 2026	View
Cardiac Guidance Caption Health, Inc. · ALT-004457 FDA	Cardiac Guidance	510k	—	Mar 2026	View
HeartFocus (V.1.1.1) Deski · ALT-004446 FDA	HeartFocus (V.1.1.1)	510k	—	Mar 2026	View
SubtleHD (1.x) Subtle Medical, Inc. · ALT-004476 FDA	SubtleHD (1.x)	510k	—	Mar 2026	View
Tyto Insights for Rhonchi Detection Tyto Care , Ltd. · ALT-004493 FDA	Tyto Insights for Rhonchi Detection	510k	—	Mar 2026	View
Fibresolve (with PCCP) Imvaria, Inc. · ALT-004625 FDA	Fibresolve (with PCCP)	510k	—	Mar 2026	View
a2z-Unified-Triage A2z Radiology Ai, Inc. · ALT-004643 FDA	a2z-Unified-Triage	510k	—	Mar 2026	View
Irregular Rhythm Notification Feature (IRNF) Apple, Inc. · ALT-006038 FDA	Irregular Rhythm Notification Feature (IRNF)	510k	—	Mar 2026	View
Sleep Apnea Notification Feature (SANF) Apple, Inc. · ALT-006065 FDA	Sleep Apnea Notification Feature (SANF)	510k	—	Mar 2026	View
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) Mighty Oak Medical · ALT-006056 FDA	Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)	510k	—	Mar 2026	View
ProFound Detection (V4.0) Icad, Inc. · ALT-006070 FDA	ProFound Detection (V4.0)	510k	—	Mar 2026	View
AiMIFY (1.x) Subtle Medical, Inc. · ALT-006061 FDA	AiMIFY (1.x)	510k	—	Mar 2026	View
FETOLY-HEART Diagnoly · ALT-006064 FDA	FETOLY-HEART	510k	—	Mar 2026	View
ScreenDx Imvaria, Inc. · ALT-006074 FDA	ScreenDx	510k	—	Mar 2026	View
MammoScreen® (4) Therapixel · ALT-006103 FDA	MammoScreen® (4)	510k	—	Mar 2026	View
Hypertension Notification Feature (HTNF) Apple, Inc. · ALT-006119 FDA	Hypertension Notification Feature (HTNF)	510k	—	Mar 2026	View
InferOperate Suite Beijing Infervision Healthcare Medical Technology Co., Ltd. · ALT-006121 FDA	InferOperate Suite	510k	—	Mar 2026	View
Ceribell Delirium Monitor System Ceribell, Inc. · ALT-006133 FDA	Ceribell Delirium Monitor System	510k	—	Mar 2026	View

Showing 26–50 of 53

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Tool	Description	Regulatory Status	Risk	Last sync
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