DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)— 510(k) K982120

Name: FDA 510(k) clearance K982120
Creator: U.S. Food and Drug Administration
Published: 1998-09-10

Substantially Equivalent

Trex Medical Corp.

FDA 510(k) clearance K982120 for DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY), Substantially Equivalent on 1998-09-10. Applicant: Trex Medical Corp.. Device class: 2.

Clearance details

Applicant: Trex Medical Corp.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1998-06-16
Decision date: 1998-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broadview, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Trex Medical Corp.

view all

K992229 — MXU-125 OR TMX-1251999-08-06
K984091 — CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 20001999-02-05
K984092 — PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-20001999-02-05
K984414 — XRE COLLIMATOR WITH SPECTRAL FILTER1998-12-30
K982427 — TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C1998-09-23

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.