PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF

System, X-ray, Mobile

UNITED RADIOLOGY SYSTEMS, INC.

The following data is part of a premarket notification filed by United Radiology Systems, Inc. with the FDA for Portable X-ray Unit, Models Pxp-15/20/40hf.

Pre-market Notification Details

• Device ID: K032628
• 510k Number: K032628
• Device Name: PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF
• Classification: System, X-ray, Mobile
• Applicant: UNITED RADIOLOGY SYSTEMS, INC. 151 SOUTH PFINGSTEN RD. UNIT T Deerfield, IL 60015
• Contact: John W Lee
• Correspondent: John W Lee; UNITED RADIOLOGY SYSTEMS, INC. 151 SOUTH PFINGSTEN RD. UNIT T Deerfield, IL 60015
• Product Code: IZL
• CFR Regulation Number: 892.1720 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-08-26
• Decision Date: 2004-02-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800040900009	K032628	000
08800040900085	K032628	000
08800040900078	K032628	000