Nexus DRF Digital X-ray Imaging System
FDA 510(k) K253103 · Varex Imaging Corporation
510(k) numberK253103
Submission
- Device name
- Nexus DRF Digital X-ray Imaging System
- Applicant
- Varex Imaging Corporation
Salt Lake City, UT, US - Received
- September 24, 2025
- Decision date
- May 29, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K251650 | Insight Enhanced DRF (EN-1002-01)JAA · Traditional | Imaging Engineering, LLC | 09/16/2025SE |
| K242488 | Soteria E-ViewJAA · Traditional | Omega Medical Imaging, LLC | 01/06/2025SE |
| K242948 | Adora DRFi (04550010)JAA · Traditional | Nrt X-Ray A/S | 12/23/2024SE |
| K233380 | TRIDENT Mobile Fluoroscopy SystemJAA · Traditional | Dornier Medtech America | 06/26/2024SE |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA · Special | Philips Medical Systems Dmc GmbH | 01/11/2024SE |
| K232910 | CombiDiagnost R90JAA · Special | Philips Medical Systems Dmc GmbH | 10/19/2023SE |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5JAA · Special | Canon Medical Systems Corporation | 09/12/2023SE |
| K220871 | NautilusJAA · Special | Dornier Medtech America, Inc. | 04/18/2022SE |
| K212890 | Nyquist.IQJAA · Traditional | Omega Medical Imaging, LLC | 12/13/2021SE |
| K212837 | ProxiDiagnost N90JAA · Special | Philips Medical Systems Dmc GmbH | 09/21/2021SE |
More from Philips Medical Systems Dmc GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K193238 | Nexus DR Digital X-Ray Imaging System (with vSharp)MQB · Special | 12/20/2019SE |
| K190146 | Nexus DR Digital X-ray Imaging SystemMQB · Special | 03/08/2019SE |
| K183212 | Nexus DR Digital X-ray Imaging System with stitchingMQB · Special | 12/07/2018SE |
| K181526 | XRpad2 4343 HWC-M Flat Panel DetectorMQB · Special | 07/03/2018SE |
| K172951 | Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)MQB · Special | 10/24/2017SE |
| K171138 | Nexus DR Digital X-ray Imaging SystemMQB · Special | 05/17/2017SE |
Questions and answers
When was Nexus DRF Digital X-ray Imaging System cleared by the FDA?
Nexus DRF Digital X-ray Imaging System (K253103) received a 510(k) decision of Substantially Equivalent on May 29, 2026, 247 days after the submission was received.
What is the product code of K253103?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.