TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C— 510(k) K982427

Name: FDA 510(k) clearance K982427
Creator: U.S. Food and Drug Administration
Published: 1998-09-23

Substantially Equivalent

Trex Medical Corp.

FDA 510(k) clearance K982427 for TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C, Substantially Equivalent on 1998-09-23. Applicant: Trex Medical Corp.. Device class: 2.

Clearance details

Applicant: Trex Medical Corp.
Product code: Code OWB
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1998-07-13
Decision date: 1998-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broadview, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.