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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 K253182
Device Name InkSpace Imaging Small Body Array (SBA12PH30x)
Applicant
Inkspace Imaging, Inc.
5635 W. Las Positas Blvd., Suite 403/404
Pleasanton,  CA  94588
Applicant Contact Peter Fischer
Correspondent
Veranex, Inc.
5420 Wade Park Blvd., Suite 204
Raleigh,  NC  27607
Correspondent Contact Valerie Defiesta-Ng
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/26/2025
Decision Date 10/20/2025
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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