Euro, SCST, Sccft Atlas Radiologic Tables

FDA 510(k) K946262 · Scott Imaging Intl., Inc.

Substantially Equivalent

510(k) numberK946262

Submission

Device name
Euro, SCST, Sccft Atlas Radiologic Tables
Applicant
Scott Imaging Intl., Inc.
Mobile, AL, US
Received
December 13, 1994
Decision date
February 15, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IXQ – Table, Radiographic, Stationary Top
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1980
Specialty
Radiology

Other 510(k)s with product code IXQ

510(k)DeviceApplicantDecision
K973842Carbon Fiber Conformal Couch TopIXQ · Traditional Medtec, Inc.12/05/1997SE
K960083Movable Cantilevered Radiographic Table XRT 100, 200 & 300IXQ · Traditional Wuestec Medical, Inc.07/24/1996SE
K954225Med-Tec Hand GripIXQ · Traditional Medtec, Inc.11/14/1995SE
K942916Octopaque UniversalIXQ · Traditional Octostop, Inc.09/08/1994SE
K942190ID100 Mobile Fluoroscopic Examining TableIXQ · Traditional Image Diagnostics, Inc.08/17/1994SE
K913425Dial-A-Rad Porta Rad TableIXQ · Traditional Dial-A-Rad11/24/1992SE
K923775R-Made Head/Arm SupportIXQ · Traditional R-Made, Inc.10/20/1992SE
K920729Bucky Table BK-12IXQ · Traditional Shimadzu Medical Systems04/27/1992SE
K914351Clinitron C-10IXQ · Traditional Ssi Medical Services, Inc.02/14/1992SE
K912382Military Radiographic Flat Table, Cat # T-9130IXQ · Traditional Continental X-Ray Corp.10/10/1991SE

More from Continental X-Ray Corp.

510(k)DeviceDecision
K946260NTBS-1417, 1436, TBS-1417IXY · Traditional 03/31/1995SE
K950041Sii 360 AprIZO · Traditional 03/21/1995SE
K950040Sii 525 AprIZO · Traditional 03/21/1995SE
K946261MTS-007, STS-008, SSMTS-010, EURO-40, 72, Super Euro 4072, 5000IYB · Traditional 02/15/1995SE
K945709Sii 525 MSKPR · Traditional 12/14/1994SE
K945708Sii 360 MSKPR · Traditional 12/14/1994SE

Questions and answers

When was Euro, SCST, Sccft Atlas Radiologic Tables cleared by the FDA?

Euro, SCST, Sccft Atlas Radiologic Tables (K946262) received a 510(k) decision of Substantially Equivalent on February 15, 1995, 64 days after the submission was received.

What is the product code of K946262?

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