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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Triage And Notification Software
510(k) Number K250694
Device Name Scaida BrainCT-ICH (v1.0)
Applicant
Mlhealth 360
Unit 204, 9900 King George Blvd.
Surrey,  CA V3T0K9
Applicant Contact Kumar Surender Sinwar
Correspondent
Product Success, Inc.
#7, 1 Aspenwood Dr.
Port Moody,  CA V3H4X8
Correspondent Contact Sujata Ghatpande
Regulation Number892.2080
Classification Product Code
QAS  
Date Received03/07/2025
Decision Date 11/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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