510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K010304Substantially Equivalent

Mxr-2000 Mobile X-Ray Unit

Irom Imaging, Inc., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010304 is the FDA 510(k) clearance record for MXR-2000 MOBILE X-RAY UNIT, a class II device, cleared for Irom Imaging, Inc. on under FDA product code IZL (System, X-Ray, Mobile). FDA records list one 510(k) clearance for Irom Imaging, Inc. As of , FDA records show no recalls naming K010304.

Clearance record

Decision date
Received
(11 days to decision)
Product code
IZL System, X-Ray, Mobile
Regulation
21 CFR 892.1720
Device class
Class II
Review panel
Radiology
Applicant
Irom Imaging, Inc. 3720 S. Lipan St., Englewood CO
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