FDA.reportPublic FDA data

510(k) K253103

Device
Nexus DRF Digital X-ray Imaging System
Applicant
Varex Imaging Corporation
510(k) number
K253103
Product code
JAA
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-29
Date received
2025-09-24
Regulation
892.1650
Classification name
System, X-Ray, Fluoroscopic, Image-Intensified
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Leah Van De Water
Address
1678 S. Pioneer Rd. Salt Lake City UT US 84104 84104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K242948Adora DRFi (04550010)Nrt X-Ray A/S2024-12-23
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K212890Nyquist.IQOmega Medical Imaging, LLC2021-12-13
K212837ProxiDiagnost N90Philips Medical Systems Dmc GmbH2021-09-21
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K210469Insight Agile DRFImaging Engineering, LLC2021-07-27
K203428Ziehm Vision RFDZiehm Imaging GmbH2021-03-17
K203010Platinum dRF Imaging SystemApelem-Dms Group2021-01-22
K200965XR-MX/1000Karl Storz Endoscopy America, Inc.2020-12-29