RMS 90/15 Radiographic/Fluoroscopic Tilting Table

FDA 510(k) K896119 · Rms Div.

Substantially Equivalent

510(k) numberK896119

Submission

Device name
RMS 90/15 Radiographic/Fluoroscopic Tilting Table
Applicant
Rms Div.
Addison, IL, US
Received
October 24, 1989
Decision date
November 27, 1989
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

Other 510(k)s with product code IXR

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K000412Vision R/F Tilting TableIXR · Traditional Villa Sistemi Medicali S.P.A.04/24/2000SE
K973039Legacy/Legacy-D TableIXR · Traditional GE Medical Systems10/16/1997SE
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

More from U.S. Imaging Tables, Inc.

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K963367RMS K-WireHTY · Traditional 10/30/1996SE
K954438Sunmed's Greenline Fiber Optic LaryngoscopeCCW · Traditional 12/29/1995SE
K944848The Vivacare T.P.S. ProbeEIX · Traditional 12/14/1994SE
K944557DW250 #91EJT · Traditional 11/03/1994SE
K941625DW234 #29EJS · Traditional 06/22/1994SE
K902403Elite R/F Spot Film DriveIXL · Traditional 08/01/1990SE
K902146SFD-035 Spot Film DeviceIXL · Traditional 05/31/1990SE
K896665EXT-600 Table, Radiographic, ElevatingIZZ · Traditional 01/22/1990SE
K896324Elite 1500 Radiographic Tilting TableIXR · Traditional 11/21/1989SE

Questions and answers

When was RMS 90/15 Radiographic/Fluoroscopic Tilting Table cleared by the FDA?

RMS 90/15 Radiographic/Fluoroscopic Tilting Table (K896119) received a 510(k) decision of Substantially Equivalent on November 27, 1989, 34 days after the submission was received.

What is the product code of K896119?

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