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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Impedance Plethysmograph, Cranial
510(k) Number K253840
Device Name STEDI Scan Device
Applicant
Stroke DX
300 Corporate Pt.E
Suite 310
Culver City,  CA  90230
Applicant Contact Richard Lilly
Correspondent
Stroke DX
300 Corporate Pt.E
Suite 310
Culver City,  CA  90230
Correspondent Contact Richard Lilly
Regulation Number870.2770
Classification Product Code
QAF  
Date Received12/01/2025
Decision Date 07/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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