510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K032628Substantially Equivalent

Portable X-Ray Unit, Models Pxp-15/20/40Hf

United Radiology Systems, Inc., Deerfield IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K032628 is the FDA 510(k) clearance record for PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF, a class II device, cleared for United Radiology Systems, Inc. on under FDA product code IZL (System, X-Ray, Mobile). FDA records list 2 510(k) clearances for United Radiology Systems, Inc., from to . As of , FDA records show no recalls naming K032628.

Clearance record

Decision date
Received
(160 days to decision)
Product code
IZL System, X-Ray, Mobile
Regulation
21 CFR 892.1720
Device class
Class II
Review panel
Radiology
Applicant
United Radiology Systems, Inc. 151 S. Pfingsten Rd.., Deerfield IL
510(k) summary
Statement
Third party review
No

Clearances, product code IZL

Trailing 12 months
7 clearances under product code IZL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IZL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20261
July 20260
August 20261
September 20260
October 20261