FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Nexus DRF Digital X-ray Imaging System
K Number: K253103
·
Decision May 29, 2026
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
7
Review Days
247
Basic Information
- Device Name
- Nexus DRF Digital X-ray Imaging System
- K Number
- K253103
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Varex Imaging Corporation
- Date Received
- September 24, 2025
- Decision Date
- May 29, 2026
- Product Code
- JAA
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
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Other Clearances by Varex Imaging Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K193238 | Nexus DR Digital X-Ray Imaging System (with vSharp) | Dec 20, 2019 | Substantially Equivalent |
| K190146 | Nexus DR Digital X-ray Imaging System | Mar 8, 2019 | Substantially Equivalent |
| K183212 | Nexus DR Digital X-ray Imaging System with stitching | Dec 7, 2018 | Substantially Equivalent |
| K181526 | XRpad2 4343 HWC-M Flat Panel Detector | Jul 3, 2018 | Substantially Equivalent |
| K172951 | Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) | Oct 24, 2017 | Substantially Equivalent |
| K171138 | Nexus DR Digital X-ray Imaging System | May 17, 2017 | Substantially Equivalent |