Trex Tilt C-Arm/Table Multipurpose Radiographic/Fluoroscopic Positioning System, Trex Tilt-C
FDA 510(k) K982427 · Trex Medical Corp.
510(k) numberK982427
Submission
- Device name
- Trex Tilt C-Arm/Table Multipurpose Radiographic/Fluoroscopic Positioning System, Trex Tilt-C
- Applicant
- Trex Medical Corp.
Broadview, IL, US - Received
- July 13, 1998
- Decision date
- September 23, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Trex Tilt C-Arm/Table Multipurpose Radiographic/Fluoroscopic Positioning System, Trex Tilt-C cleared by the FDA?
Trex Tilt C-Arm/Table Multipurpose Radiographic/Fluoroscopic Positioning System, Trex Tilt-C (K982427) received a 510(k) decision of Substantially Equivalent on September 23, 1998, 72 days after the submission was received.
What is the product code of K982427?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.