# K143281: Ultimax-i

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jan 29, 2015 after 76 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K801623 (1980). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133553: Kalare, Toshiba America Medical Systems, In.C (2014) Summary page 4.
- K122644: Artis Zee/Zeego with CSX-10 Detector SW VC21, Siemens Medical Solutions USA, Inc. (2013). Our reading of the summary gave K122664, FDA’s number for Zuga Dental Implant System (Zuga Medical, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Siemens Medical Systems, Artis Zee Multi-purpose”.

## 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. This system is not intended for mammography studies in the US.

Source page: https://510kreport.com/device/K143281
Methodology: https://510kreport.com/methodology