510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K893637Substantially Equivalent

Mc125l-50 Shimadzu Mobile X-Ray System

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

K893637 is the FDA 510(k) clearance record for MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM, a class II device, cleared for Shimadzu Medical Systems on under FDA product code IZL (System, X-Ray, Mobile). FDA records list 90 510(k) clearances for Shimadzu Medical Systems, from to . As of , FDA records show no recalls naming K893637.

Clearance record

Decision date
Received
(69 days to decision)
Product code
IZL System, X-Ray, Mobile
Regulation
21 CFR 892.1720
Device class
Class II
Review panel
Radiology
Applicant
Shimadzu Medical Systems 101 W. Walnut St., Gardena CA
Third party review
No

Clearances, product code IZL

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