Atlas FDA

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

Trex Medical Corp. — Predicate Candidate Screening

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

81 daysmedian FDA review time
86 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K992229MXU-125 OR TMX-125Trex Medical Corp.1999-08-06350
K984091CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000Trex Medical Corp.1999-02-05810
K984092PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000Trex Medical Corp.1999-02-05810
K984414XRE COLLIMATOR WITH SPECTRAL FILTERTrex Medical Corp.1998-12-30200
K982427TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPICTrex Medical Corp.1998-09-23720
K982120DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-20Trex Medical Corp.1998-09-10860

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