Xre Collimator with Spectral Filter

Q: What is the product code of K984414?

The FDA product code is IZW – Collimator, Automatic, Radiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1610.

FDA 510(k) K984414 · Trex Medical Corp.

Substantially Equivalent

510(k) numberK984414

Submission

Device name: Xre Collimator with Spectral Filter
Applicant: Trex Medical Corp.
Littleton, MA, US
Received: December 10, 1998
Decision date: December 30, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: IZW – Collimator, Automatic, Radiographic
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1610
Specialty: Radiology

Other 510(k)s with product code IZW

510(k)	Device	Applicant	Decision
K101039	Shimadzu Collimator R-300IZW · Abbreviated	Shimadzu Corp.	09/20/2010SE
K093572	R650 Qdasm CollimatorIZW · Traditional	Omega Medical Imaging, Inc.	02/03/2010SE
K090578	Shimadzu Collimator R-30HIZW · Abbreviated	Shimadzu Corp.	11/06/2009SE
K091517	Ralco, Model R225 AcsIZW · Traditional	Ralco S.R.L.	07/14/2009SE
K083029	Model R605DASM Automatic X-Ray CollimatorIZW · Traditional	Ralco S.R.L.	12/05/2008SE
K072780	Model R302DACS/A Automatic X-Ray CollimatorIZW · Traditional	Ralco S.R.L.	11/26/2007SE
K073124	Collimare Collimator FamilyIZW · Abbreviated	Collimare, LLC	11/16/2007SE
K050092	R605 Facs CollimeterIZW · Traditional	Omega Medical Imaging, Inc.	01/31/2005SE
K031597	Dunlee Format Collimator FamilyIZW · Traditional	Philips Medical Systems North America Co.	07/21/2003SE
K990423	Philips Nicol Collimator FamilyIZW · Traditional	Philips Medical Systems, Inc.	03/15/1999SE

More from Philips Medical Systems, Inc.

510(k)	Device	Decision
K992229	MXU-125 or TMX-125IZL · Traditional	08/06/1999SE
K984092	Profile 2000 Mammography System, PRO-2000IZH · Traditional	02/05/1999SE
K984091	Contour 2000 Mammography System, Model Ctr- 2000IZH · Traditional	02/05/1999SE
K982427	Trex Tilt C-Arm/Table Multipurpose Radiographic/Fluoroscopic Positioning System, Trex…OWB · Traditional	09/23/1998SE
K982120	Digital Imaging System, Models DIGITREX-1000 and DIGITREX-2000 (DIGITREX-X000 Family)LLZ · Traditional	09/10/1998SE

Questions and answers

When was Xre Collimator with Spectral Filter cleared by the FDA?

Xre Collimator with Spectral Filter (K984414) received a 510(k) decision of Substantially Equivalent on December 30, 1998, 20 days after the submission was received.

What is the product code of K984414?

The FDA product code is IZW – Collimator, Automatic, Radiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1610.