# K080701: Shimadzu Mobile X-Ray System Mobiledart Evolution

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Corp.
- Decided: May 14, 2008 after 64 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Nov 9, 2020 · Class II · Z-0534-2021: There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of indi
- Jul 19, 2019 · Class II · Z-2441-2019: The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)
- Jan 15, 2019 · Class II · Z-1040-2019: FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released.
- Jan 14, 2019 · Class II · Z-1039-2019: In these units, the brake is usually released by gripping the drive handle and applied by letting go of the handle. However, for systems within a specified manufacture period, we have identified that 
- Nov 10, 2015 · Class II · Z-0451-2016: The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly.
- Mar 18, 2013 · Class II · Z-1369-2013: The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in combination with CXDI-70C, CXDI-55C, and CX
- Oct 28, 2011 · Class II · Z-0265-2013: 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. Exposure can be captured on film, CR or Digital Radiography (DR)

Source page: https://510kreport.com/device/K080701
Methodology: https://510kreport.com/methodology