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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K250749
Device Name PhysCade System
Applicant
Physcade, Inc.
2100 Geng Rd., Suite 210
Palo Alto,  CA  94303
Applicant Contact Raphael Michel
Correspondent
Physcade, Inc.
2100 Geng Rd., Suite 210
Palo Alto,  CA  94303
Correspondent Contact Grace Li
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/12/2025
Decision Date 06/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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