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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K240465
Device Name O-arm O2 Imaging System
Applicant
Medtronic Navigation, Inc
200 Beaver Brook Rd
Boxborough,  MA  01719
Applicant Contact Anamika Patel
Correspondent
Medtronic Navigation, Inc
200 Beaver Brook Rd
Boxborough,  MA  01719
Correspondent Contact Anamika Patel
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received02/16/2024
Decision Date 06/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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