Model Alpha TS-2

FDA 510(k) K935004 · Dpa Consulting, Inc.

Substantially Equivalent

510(k) numberK935004

Submission

Device name
Model Alpha TS-2
Applicant
Dpa Consulting, Inc.
Urbanna, VA, US
Received
October 19, 1993
Decision date
December 13, 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
K933253Superstand 3000IYB · Traditional Wuestec Medical, Inc.08/16/1993SE
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

Questions and answers

When was Model Alpha TS-2 cleared by the FDA?

Model Alpha TS-2 (K935004) received a 510(k) decision of Substantially Equivalent on December 13, 1993, 55 days after the submission was received.

What is the product code of K935004?

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