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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K233444
Device Name InkSpace Imaging Small Body Array
Applicant
Inkspace Imaging, Inc.
5635 W. Las Positas Blvd., Suite 403/404
Pleasanton,  CA  94588
Applicant Contact Peter Fischer
Correspondent
Veranex, Inc.
224 Airport Pkwy., Suite 250
San Jose,  CA  95110
Correspondent Contact Taras Bouzakine
Regulation Number892.1000
Classification Product Code
MOS  
Date Received10/19/2023
Decision Date 01/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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