Surgical C-Arm Table, 9610

FDA 510(k) K953557 · U.S. Imaging Tables, Inc.

Substantially Equivalent

510(k) numberK953557

Submission

Device name
Surgical C-Arm Table, 9610
Applicant
U.S. Imaging Tables, Inc.
Northport, NY, US
Received
July 17, 1995
Decision date
September 26, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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

510(k)DeviceApplicantDecision
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
K953556Vacs Table, 9650IXR · Traditional U.S. Imaging Tables, Inc.09/26/1995SE

More from U.S. Imaging Tables, Inc.

510(k)DeviceDecision
K965105Electrophysiology Tilt Table Model #9660IXR · Traditional 01/30/1997SE
K965096Fluoroview Series Fluoroscopic TablesIXR · Traditional 01/27/1997SE
K953556Vacs Table, 9650IXR · Traditional 09/26/1995SE

Questions and answers

When was Surgical C-Arm Table, 9610 cleared by the FDA?

Surgical C-Arm Table, 9610 (K953557) received a 510(k) decision of Substantially Equivalent on September 26, 1995, 71 days after the submission was received.

What is the product code of K953557?

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