Aluminum Filtration System

FDA 510(k) K811450 · Wedge Filtration System

Substantially Equivalent

510(k) numberK811450

Submission

Device name
Aluminum Filtration System
Applicant
Wedge Filtration System
Mchenry, IL, US
Received
May 22, 1981
Decision date
July 2, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KPW – Device, Beam Limiting, X-Ray, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1610
Specialty
Radiology

Other 510(k)s with product code KPW

510(k)DeviceApplicantDecision
K093596Lumos, Model R 72BKPW · Traditional Lumos, Inc.01/12/2010SE
K062788Collimator, Model M-38KPW · Traditional Umi International12/28/2006SE
K030487R 72KPW · Traditional Ralco S.R.L.08/01/2003SE
K954310BLA-800AKPW · Traditional Toshiba Medical Systems10/18/1995SE
K946320R 302KPW · Traditional Ralco S.R.L.05/11/1995SE
K914184P2020-8-0 Beam-Limiting DeviceKPW · Traditional Precise Optics11/27/1991SE
K904587Densicomp 250KPW · Traditional L. Keroack Co.01/24/1991SE
K904044TF-63SAKPW · Traditional Toshiba America Medical Systems, In.C11/29/1990SE
K904489Eureka Extension CylindersKPW · Traditional Eureka X-Ray Tube Corp.10/15/1990SE
K820306Ralco Collimator, Automatic RadiographicKPW · Traditional Tecnomed, Inc.03/05/1982SE

Questions and answers

When was Aluminum Filtration System cleared by the FDA?

Aluminum Filtration System (K811450) received a 510(k) decision of Substantially Equivalent on July 2, 1981, 41 days after the submission was received.

What is the product code of K811450?

The FDA product code is KPW – Device, Beam Limiting, X-Ray, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1610.