# K041763: Shimadzu Mobile X-Ray System Mux-100D Series

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Corp.
- Decided: Jul 13, 2004 after 13 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
42 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K120062: DRX-Revolution Mobile X-Ray System (2012), 41 descendants of its own
- K123526: Clearread +Confirm (2012), 25 descendants of its own
- K162278: Digital Diagnostic Mobile X-ray System (2016), 23 descendants of its own
- K171119: GM85 (2017), 22 descendants of its own
- K173828: GU60A & GU60A-65 (2018), 19 descendants of its own

## Recalls of this device
- Oct 28, 2011 · Class II · Z-0263-2013: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m)

## Indications for use
This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. This device is operated and used by Physicians and X-ray technologist. The object of this device is total patient populations. Exposure can be captured on film, CR or Digital Radiography (DR)

Source page: https://510kreport.com/device/K041763
Methodology: https://510kreport.com/methodology