FDA 510(k) clearance · back to tracker

Nexus DRF Digital X-ray Imaging System

Varex Imaging Corporation cleared K253103 on 2026-05-29, decision: substantially equivalent

K-number

K253103

Sponsor

Varex Imaging Corporation

Device

Nexus DRF Digital X-ray Imaging System

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-29

Product code

JAA

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1650

Official FDA record

Open K253103on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.