Rastix X-Ray Table

FDA 510(k) K883155 · Bay X-Ray, Inc.

Substantially Equivalent

510(k) numberK883155

Submission

Device name
Rastix X-Ray Table
Applicant
Bay X-Ray, Inc.
Walnut Creek, CA, US
Received
July 26, 1988
Decision date
September 6, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KXJ – Table, Radiologic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1980
Specialty
Radiology

Other 510(k)s with product code KXJ

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K050190ApolloKXJ · Abbreviated Villa Sistemi Medicali S.P.A.03/25/2005SE
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K955414XRT 400KXJ · Traditional Wuestec Medical, Inc.07/24/1996SE
K951146Imaging TableKXJ · Traditional Septa Corp.05/04/1995SE
K950068Carbon Fiber Couch InsertKXJ · Traditional Medtec, Inc.04/06/1995SE
K950442Infrared Exposure Hand SwitchKXJ · Traditional Medical X-Ray Intl., Inc.03/31/1995SE
K940696Syncra Tilt Option for Angio Diagnost 5KXJ · Traditional Philips Medical Systems North America, Inc.03/16/1994SE
K931724Electrophysiology (Ep) Table Ep 2000 SeriesKXJ · Traditional Continental X-Ray Corp.06/14/1993SE
K926407Model Cole TAB-2 Table W/Model Cole SFD-2 SpotfilmKXJ · Traditional Nucletron-Oldelft Corp.03/31/1993SE
K922098CAG-02AKXJ · Traditional Toshiba America Medical Systems, In.C07/27/1992SE

More from Toshiba America Medical Systems, In.C

510(k)DeviceDecision
K883161Himobilix 2NJAA · Traditional 10/21/1988SE
K883160Catapult Bucky (Katapult Blenda)KPR · Traditional 09/08/1988SE
K883162Telestatix X-Ray TableIXR · Traditional 09/06/1988SE
K883154Seldix 325 Two Pulse Generator/ControlIZO · Traditional 09/06/1988SE
K883153Undistat with Explorator 35 (Ucs 35E)IXR · Traditional 09/06/1988SE

Questions and answers

When was Rastix X-Ray Table cleared by the FDA?

Rastix X-Ray Table (K883155) received a 510(k) decision of Substantially Equivalent on September 6, 1988, 42 days after the submission was received.

What is the product code of K883155?

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