Motor Tilted Exam. Table UV-56

FDA 510(k) K840226 · Medicor USA , Ltd.

Substantially Equivalent

510(k) numberK840226

Submission

Device name
Motor Tilted Exam. Table UV-56
Applicant
Medicor USA , Ltd.
Mchenry, IL, US
Received
January 19, 1984
Decision date
March 16, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IXR – Table, Radiographic, Tilting
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1980
Specialty
Radiology

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K971128CAP-35B Iii/Cine 275IXR · Traditional Jamieson Film Co.04/28/1997SE
K970640Philips Easy DiagnostIXR · Traditional Philips Medical Systems North America, Inc.03/21/1997SE
K965105Electrophysiology Tilt Table Model #9660IXR · Traditional U.S. Imaging Tables, Inc.01/30/1997SE
K965096Fluoroview Series Fluoroscopic TablesIXR · Traditional U.S. Imaging Tables, Inc.01/27/1997SE
K963851Tilting Radiographic Table (Remote)IXR · Traditional Acoma Medical Imaging, Inc.01/23/1997SE
K961022Tangent Vi TableIXR · Traditional Fischer Imaging Corp.05/03/1996SE
K954356Compax 90/15EIXR · Traditional General Electric Co.10/07/1995SE
K953557Surgical C-Arm Table, 9610IXR · Traditional U.S. Imaging Tables, Inc.09/26/1995SE

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K850761Model Pcx/Emy 525A Microprocesssor Control X-Ray CBZN · Traditional 09/19/1985SE
K851358Model Bion 2/TYPE 90 Room IonizerFRF · Traditional 07/01/1985SE
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K843335Floor Mounted X-Ray TubestandIYB · Traditional 11/27/1984SE
K840227UROLIX-3 Urological TableIXR · Traditional 03/23/1984SE
K840225C-Arm Ceiling Crane FT-2JAA · Traditional 03/22/1984SE
K823695CPM Metabolic MonitorBZL · Traditional 01/14/1983SE

Questions and answers

When was Motor Tilted Exam. Table UV-56 cleared by the FDA?

Motor Tilted Exam. Table UV-56 (K840226) received a 510(k) decision of Substantially Equivalent on March 16, 1984, 57 days after the submission was received.

What is the product code of K840226?

The FDA product code is IXR – Table, Radiographic, Tilting, a Class II (moderate risk) device regulated under 21 CFR 892.1980.