# K943545: Ceiling Suspended C-Arm Support MH-100

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Medical Systems
- Decided: Feb 3, 1995 after 197 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K071717: GE Oec Altitude (2007), 0 descendants of its own
- K052039: GE Oec Altitude (2005), 0 descendants of its own

## Recalls of this device
- Nov 18, 2020 · Class II · Z-0556-2021: The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has relea

Source page: https://510kreport.com/device/K943545
Methodology: https://510kreport.com/methodology