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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 K241719
Device Name NeuroICH
Applicant
Neurocareai, Inc.
8992 Preston Rd. Suite 110-255
Frisco,  TX  75034
Applicant Contact Junaid Saddiq Kalia
Correspondent
Neurocareai, Inc.
8992 Preston Rd. Suite 110-255
Frisco,  TX  75034
Correspondent Contact Junaid Siddiq Kalia
Regulation Number892.2080
Classification Product Code
QAS  
Date Received06/14/2024
Decision Date 11/07/2024
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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