Varex Imaging Corporation: FDA clearances and approvals
Varex Imaging Corporation has 7 FDA 510(k) clearances (first 2017, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 28 days. Since 2017 its median was 28 days, against 33 days for all cleared 510(k)s in the same product codes. It files with the SEC as Varex Imaging Corp (VREX).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 2 | 28 |
| 2018 | 2 | 20 |
| 2019 | 2 | 32 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 247 |
Review time against the same product codes
Since 2017, Varex Imaging Corporation's cleared 510(k)s took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 33 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 6 | 6 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
Review panels
- Radiology (7)
Most recent Varex Imaging Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253103 | Nexus DRF Digital X-ray Imaging System | JAA | 2026-05-29 | 247 |
| K193238 | Nexus DR Digital X-Ray Imaging System (with vSharp) | MQB | 2019-12-20 | 25 |
| K190146 | Nexus DR Digital X-ray Imaging System | MQB | 2019-03-08 | 38 |
| K183212 | Nexus DR Digital X-ray Imaging System with stitching | MQB | 2018-12-07 | 18 |
| K181526 | XRpad2 4343 HWC-M Flat Panel Detector | MQB | 2018-07-03 | 22 |
| K172951 | Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) | MQB | 2017-10-24 | 28 |
| K171138 | Nexus DR Digital X-ray Imaging System | MQB | 2017-05-17 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Varex Imaging Corporation.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
SEC filings
Varex Imaging Corp (VREX): EDGAR filings, CIK 1681622. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Varex Imaging Corporation have?
Varex Imaging Corporation has 7 FDA 510(k) clearances (first 2017, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Varex Imaging Corporation's 510(k)s?
The median time from FDA receipt to decision across Varex Imaging Corporation's cleared 510(k)s is 28 days. Since 2017: 28 days, versus 33 days for all cleared 510(k)s in the same product codes.
What devices does Varex Imaging Corporation make?
Its most frequent FDA product codes are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 6); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 1).
Has Varex Imaging Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Varex Imaging Corporation. Related entities may recall under other names.
Next steps
- See all 7 Varex Imaging Corporation clearances with predicates and recalls
- Run predicate analysis for product code MQB, Varex Imaging Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.