Carolina X-Ray Co. Simplafloat Table

FDA 510(k) K842614 · Carolina X-Ray Co., Inc.

Substantially Equivalent

510(k) numberK842614

Submission

Device name
Carolina X-Ray Co. Simplafloat Table
Applicant
Carolina X-Ray Co., Inc.
Mchenry, IL, US
Received
July 5, 1984
Decision date
August 8, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K946262Euro, SCST, Sccft Atlas Radiologic TablesIXQ · Traditional Scott Imaging Intl., Inc.02/15/1995SE
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

Questions and answers

When was Carolina X-Ray Co. Simplafloat Table cleared by the FDA?

Carolina X-Ray Co. Simplafloat Table (K842614) received a 510(k) decision of Substantially Equivalent on August 8, 1984, 34 days after the submission was received.

What is the product code of K842614?

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