Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

Varex Imaging Corporation

Franklin Park, IL, US

Varex Imaging Corporation appears in FDA device records in Franklin Park, IL. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 7 510(k) clearances for Varex Imaging Corporation between 2017 and 2026. The busiest year on record is 2017, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Varex Imaging Corporation, by decision year
YearClearances
20172
20182
20192
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253103Nexus DRF Digital X-ray Imaging SystemJAASubstantially Equivalent
K193238Nexus DR Digital X-Ray Imaging System (with vSharp)MQBSubstantially Equivalent
K190146Nexus DR Digital X-ray Imaging SystemMQBSubstantially Equivalent
K183212Nexus DR Digital X-ray Imaging System with stitchingMQBSubstantially Equivalent
K181526XRpad2 4343 HWC-M Flat Panel DetectorMQBSubstantially Equivalent
K172951Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)MQBSubstantially Equivalent
K171138Nexus DR Digital X-ray Imaging SystemMQBSubstantially Equivalent

Registered establishments

FDA registered establishments for Varex Imaging Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
14832911483291Varex Imaging Corporation3835 Carnation St, Franklin Park, IL 60131 US2026
17178551717855Varex Imaging Corporation1678 South Pioneer Road, SALT LAKE CITY, UT 84104 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Varex Imaging Corporation edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain