510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920393Substantially Equivalent

Mu125m Mobile X-Ray System

Shimadzu Medical Systems, Gardena CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920393 is the FDA 510(k) clearance record for MU125M MOBILE X-RAY SYSTEM, a class II device, cleared for Shimadzu Medical Systems on under FDA product code IZG (System, X-Ray, Photofluorographic). FDA records list 90 510(k) clearances for Shimadzu Medical Systems, from to . As of , FDA records show no recalls naming K920393.

Clearance record

Decision date
Received
(67 days to decision)
Product code
IZG System, X-Ray, Photofluorographic
Regulation
21 CFR 892.1730
Device class
Class II
Review panel
Radiology
Applicant
Shimadzu Medical Systems 101 W. Walnut St., Gardena CA
510(k) summary
Statement
Third party review
No

Clearances, product code IZG

Trailing 12 months

FDA records hold no clearances under product code IZG in the trailing twelve months.

FDA records show no clearances under product code IZG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IZG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260