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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K252249
Device Name Extremity CT Imaging System
Applicant
Mars Bioimaging , Ltd.
68 St. Asaph St.
Central City
Christchurch,  NZ 8011
Applicant Contact Homi Dalal
Correspondent
MEDIcept
200 Homer Ave.,
Ashland,  MA  01721
Correspondent Contact Melissa DeHass
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/18/2025
Decision Date 03/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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