510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K992229Substantially Equivalent

Mxu-125 or Tmx-125

Trex Medical Corp., Danbury CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992229 is the FDA 510(k) clearance record for MXU-125 OR TMX-125, a class II device, cleared for Trex Medical Corp. on under FDA product code IZL (System, X-Ray, Mobile). FDA records list 6 510(k) clearances for Trex Medical Corp., from to . As of , FDA records show no recalls naming K992229.

Clearance record

Decision date
Received
(35 days to decision)
Product code
IZL System, X-Ray, Mobile
Regulation
21 CFR 892.1720
Device class
Class II
Review panel
Radiology
Applicant
Trex Medical Corp. 36 Apple Ridge Rd., Danbury CT
510(k) summary
Summary
Third party review
No

Clearances, product code IZL

Trailing 12 months
6 clearances under product code IZL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IZL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20261
July 20260
August 20261
September 20260
October 20260