TC+ SYSTEM (TILTING C-ARM SYSTEM)— 510(k) K936180

Name: FDA 510(k) clearance K936180
Creator: U.S. Food and Drug Administration
Published: 1994-03-16

Substantially Equivalent

GE Medical Systems

FDA 510(k) clearance K936180 for TC+ SYSTEM (TILTING C-ARM SYSTEM), Substantially Equivalent on 1994-03-16. Applicant: GE Medical Systems. Device class: 2.

Clearance details

Applicant: GE Medical Systems
Product code: Code OWB
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1993-12-27
Decision date: 1994-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, 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 →

Recalls naming K936180

K-number listed on FDA's recall record

Z-0804-2014 — Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII Product Usage: The systems are intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations on both adult and pediatric subjects. The systmes are used for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.Class II·Terminated·GE Healthcare, LLC·20131108

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K936180.

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