Portable Supine Patient Support and Cassette Holder

FDA 510(k) K081557 · Jddb Manufacturing, Inc.

Substantially Equivalent

510(k) numberK081557

Submission

Device name
Portable Supine Patient Support and Cassette Holder
Applicant
Jddb Manufacturing, Inc.
Riverdale, IL, US
Received
June 3, 2008
Decision date
September 10, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IXA – Cassette, Radiographic Film
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1850
Specialty
Radiology

Other 510(k)s with product code IXA

510(k)DeviceApplicantDecision
K053173DS CassetteIXA · Traditional Konica Minolta Medical & Graphic, Inc.12/15/2005SE
K040378Kodak Directview CR CASSETTE/GP/15 X 30 CM, Catalog# 8418253IXA · Traditional Eastman Kodak Company05/24/2004SE
K023020Agfa Mamoray Mammographic Cassette, Agfa Metal-Bodied Cawo Cassette, Agfa Curix and…IXA · Traditional Agfa Corp.09/26/2002SE
K021903Kodak X-Omat Cassette/Leadless for Dental UseIXA · Special Eastman Kodak Company07/10/2002SE
K013686Kodak Directview Tabletop CassetteIXA · Special Eastman Kodak Company12/07/2001SE
K013229Liferay FW Mammo Cassette, Liferay KW Mammo CasetteIXA · Traditional Ferrania USA, Inc.10/12/2001SE
K012373Liferay WL Cassette, Liferay KW CassetteIXA · Traditional Ferrania S.P.A.08/09/2001SE
K983918Radiolucent Cassette Limb Positioner (R-Clip)IXA · Traditional Mastek, Inc.03/12/1999SE
K980722Trimax Radiographic CassetteIXA · Traditional Imation Corp.03/23/1998SE
K963914CM & CM DS-7IXA · Traditional Konica Medical Corp.10/08/1997SE

Questions and answers

When was Portable Supine Patient Support and Cassette Holder cleared by the FDA?

Portable Supine Patient Support and Cassette Holder (K081557) received a 510(k) decision of Substantially Equivalent on September 10, 2008, 99 days after the submission was received.

What is the product code of K081557?

The FDA product code is IXA – Cassette, Radiographic Film, a Class II (moderate risk) device regulated under 21 CFR 892.1850.