# K251295: ulrichINJECT CT Motion (XD 8000)

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich GmbH & Co. KG
- Decided: Nov 7, 2025 after 196 days
- Product code: IZQ (Injector, Contrast Medium, Automatic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- 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 K934086 (1995). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210541: ulrichINJECT CT motion, Ulrich GmbH & Co. KG (2021) Summary page 6.

## Indications for use
ulrichINJECT CT motion is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in computed tomography (CT) applications. ulrichINJECT CT motion is specifically indicated for use in CT procedures for the delivery of the following contrast media: • Iohexol Injection in single-dose (SD) container or Imaging Bulk Package (IBP) • Iodixanol Injection in SD container • Iopamidol Injection in IBP Pump tubing – flex can be used with a maximum of 36 bottles of contrast media or a maximum time of twenty-four (24) hours, whichever comes first. Use time expiration per SD container is a maximum of four (4) hours from initial puncture, unless otherwise stated by the contrast media labeling. Use time expiration per IBP is limited to a maximum time stated by the specific contrast media labeling. Use time expiration per saline container is a maximum of twenty four (24) hours from initial puncture. Spike for CT disposable is for single-bottle use only and must be discarded with the media container. The maximum time usage for the Spike for CT is twenty four (24) hours, or the maximum use time for the contrast media container indicated for use with ulrichINJECT CT motion, whichever comes first. The Patient tubing must be discarded after each patient procedure. SYNCopen is indicated for the specific purpose of allowing an injector to interface with a CT scanner. RIS/PACS is indicated for the specific purpose of allowing an injector to interface with a Radiological Information System (RIS) and a Picture Archiving and Communications System (PACS). ulrichINJECT CT motion is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast media.

Source page: https://510kreport.com/device/K251295
Methodology: https://510kreport.com/methodology