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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K252579
Device Name Orthoscan TAU MVP Mini C-Arm System
Applicant
Ziehm-Orthoscan, Inc.
14555 N 82nd St.
Scottsdale,  AZ  85260
Applicant Contact Kevin Bridgman
Correspondent
Ziehm-Orthoscan, Inc.
14555 N 82nd St.
Scottsdale,  AZ  85260
Correspondent Contact Kevin Bridgman
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Codes
GCJ   HRX   JAA   MQB  
Date Received08/15/2025
Decision Date 01/14/2026
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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