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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 K241567
Device Name MC2 Portable X-ray System
Applicant
Oxos Medical
1100 Peachtree St NE
Ste 700
Atlanta,  GA  30309
Applicant Contact Dhruv Vishwakarma
Correspondent
Powers Regulatory Consulting
1100 Peachtree St NE
STE 700
Atlanta,  GA  30309
Correspondent Contact Dhruv Vishwakarma
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
IZL   OXO  
Date Received05/31/2024
Decision Date 12/06/2024
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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