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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 K213113
Device Name Orthoscan Tau Mini C-Arm
Applicant
Orthoscan, Inc.
14555 N. 82nd St.
Scottsdale,  AZ  85260
Applicant Contact Kevin Bridgman
Correspondent
Orthoscan, Inc.
14555 N. 82nd St.
Scottsdale,  AZ  85260
Correspondent Contact Kevin Bridgman
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Codes
JAA   MQB  
Date Received09/27/2021
Decision Date 10/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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