Collimator, Model M-38

FDA 510(k) K062788 · Umi International

Substantially Equivalent

510(k) numberK062788

Submission

Device name
Collimator, Model M-38
Applicant
Umi International
Norwood, NJ, US
Received
September 18, 2006
Decision date
December 28, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
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
K820305Ralco Collimators, Manual RadiographicKPW · Traditional Tecnomed, Inc.03/04/1982SE

Questions and answers

When was Collimator, Model M-38 cleared by the FDA?

Collimator, Model M-38 (K062788) received a 510(k) decision of Substantially Equivalent on December 28, 2006, 101 days after the submission was received.

What is the product code of K062788?

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