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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K253103
Device Name Nexus DRF Digital X-ray Imaging System
Applicant
Varex Imaging Corporation
1678 S. Pioneer Rd.
Salt Lake City,  UT  84104
Applicant Contact Leah Van De Water
Correspondent
Varex Imaging Corporation
1678 S. Pioneer Rd.
Salt Lake City,  UT  84104
Correspondent Contact Leah Van De Water
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
MQB  
Date Received09/24/2025
Decision Date 05/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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