510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K012379Substantially Equivalent

Pdx-2000 Portable Digital X-Ray System

Trex Enterprises Corp., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012379 is the FDA 510(k) clearance record for PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM, a class II device, cleared for Trex Enterprises Corp. on under FDA product code IZL (System, X-Ray, Mobile). FDA records list one 510(k) clearance for Trex Enterprises Corp. As of , FDA records show no recalls naming K012379.

Clearance record

Decision date
Received
(21 days to decision)
Product code
IZL System, X-Ray, Mobile
Regulation
21 CFR 892.1720
Device class
Class II
Review panel
Radiology
Applicant
Trex Enterprises Corp. 10455 Pacific Center Ct., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code IZL

Trailing 12 months
7 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 20261