Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Varex Imaging Corporation · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

28 daysmedian FDA review time
247 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging Corporation2026-05-292470
K193238Nexus DR Digital X-Ray Imaging System (with vSharp)Varex Imaging Corporation2019-12-20250
K190146Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation2019-03-08380
K183212Nexus DR Digital X-ray Imaging System with stitchingVarex Imaging Corporation2018-12-07180
K181526XRpad2 4343 HWC-M Flat Panel DetectorVarex Imaging Corporation2018-07-03220
K172951Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC aVarex Imaging Corporation2017-10-24280
K171138Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation2017-05-17290

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda