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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 K151000
Device Name O-Arm O2 Imaging System
Applicant
Medtronic, Inc.
300 Foster St.
Littleton,  MA  01460
Applicant Contact RISHI SINHA
Correspondent
Medtronic, Inc.
300 Foster St.
Littleton,  MA  01460
Correspondent Contact RISHI SINHA
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received04/15/2015
Decision Date 08/06/2015
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
Recalls CDRH Recalls
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