Superstand 3000

FDA 510(k) K933253 · Wuestec Medical, Inc.

Substantially Equivalent

510(k) numberK933253

Submission

Device name
Superstand 3000
Applicant
Wuestec Medical, Inc.
Mobile, AL, US
Received
July 2, 1993
Decision date
August 16, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IYB – Tube Mount, X-Ray, Diagnostic
Device class
Class I (low risk)
Regulation
21 CFR 892.1770
Specialty
Radiology

Other 510(k)s with product code IYB

510(k)DeviceApplicantDecision
K935123Superstand 300IYB · Traditional Wuestec Medical, Inc.03/27/1996SE
K946261MTS-007, STS-008, SSMTS-010, EURO-40, 72, Super Euro 4072, 5000IYB · Traditional Scott Imaging Intl., Inc.02/15/1995SE
K941017F/C/W TubestandIYB · Traditional Acoma Medical Imaging, Inc.07/29/1994SE
K941004CTS SystemIYB · Traditional Acoma Medical Imaging, Inc.07/29/1994SE
K940442MPR-814IYB · Traditional Xri, Inc.06/09/1994SE
K935004Model Alpha TS-2IYB · Traditional Dpa Consulting, Inc.12/13/1993SE
K925716Bennett Overhead Tube Crane Model No. B-OtcIYB · Traditional Bennett X-Ray Corp.12/17/1992SE
K925170Shimadzu X-Ray Tube Stand BH-100 SeriesIYB · Traditional Shimadzu Medical Systems12/07/1992SE
K920727Ceiling Tube Support CH-30XIYB · Traditional Shimadzu Medical Systems04/16/1992SE
K914944Bennett Overhead Tube Crane Model No. B-OtcIYB · Traditional Bennett X-Ray Corp.12/02/1991SE

More from Bennett X-Ray Corp.

510(k)DeviceDecision
K993962Pensil Trauma, Model WWS6100KPR · Traditional 12/21/1999SE
K992603XRT 600 R/F, WRF 0600JAA · Traditional 10/25/1999SE
K992103C-QuestOWB · Traditional 09/01/1999SE
K981880DX-480, Add on Digital ImagerKPR · Traditional 10/20/1998SE
K974240Lightline-MIZX · Traditional 12/22/1997SE
K960083Movable Cantilevered Radiographic Table XRT 100, 200 & 300IXQ · Traditional 07/24/1996SE
K955414XRT 400KXJ · Traditional 07/24/1996SE
K935123Superstand 300IYB · Traditional 03/27/1996SE

Questions and answers

When was Superstand 3000 cleared by the FDA?

Superstand 3000 (K933253) received a 510(k) decision of Substantially Equivalent on August 16, 1993, 45 days after the submission was received.

What is the product code of K933253?

The FDA product code is IYB – Tube Mount, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1770.