# K181834: Ultimax-i, DREX-UI80 (V1.60)

- Pathway: 510(k) (Special)
- Applicant: Canon Medical Systems Corporation
- Decided: Jul 19, 2018 after 9 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K170832 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170832: Ultimax-i, DREX-UI80 V1.60, Toshibamedical Systems Corporation (2017) Summary page 5.

## Recalls of this device
- Jul 8, 2020 · Class II · Z-2885-2020: During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the same as originally acquired.

## Indications for use
The Ultimax-i multipurpose digital X-ray system is designed for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The Ultimax-i system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast-enhanced studies, nonvascular IVR , vascular contrast-enhanced studies, support of vascular IVR, and general radiography. Note: This system is not intended for cardiovascular contrast studies or interventional radiology procedures for the cardiac or cerebral blood vessels.

Source page: https://510kreport.com/device/K181834
Methodology: https://510kreport.com/methodology