# K062265: CT Expres Iii Contrast Media Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Swiss Medical Care S.A.
- Decided: Dec 26, 2006 after 144 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: 2 generations back to K934086 (1995). 2 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983314: Premica CT Contrast Media Delivery System, Nycomed Amersham Imaging (1999) Summary page 1.

## Most influential descendants
- K151048: CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set (2016), 9 descendants of its own
- K171392: ulrichINJECT CT motion (2017), 6 descendants of its own
- K192872: ulrichINJECT CT Motion (2020), 5 descendants of its own
- K233737: ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (2024), 2 descendants of its own
- K241849: MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) (2024), 1 descendant of its own

## Indications for use
The CT Expres III™ Contrast Media Delivery System (CMDS) is indicated for controlled automatic administration, on the venous side, of contrast media (CM) to human subjects while undergoing examination by means of a computed tomography (CT) scanner. The system consists of the CT Expres III™ Instrument, the Bottle Spike, the Day Set III, the Patient Set, accessories and detachable parts. This device is not intended for injection of CM for coronary arteriography, or for any other use for which the device is not indicated. This device is only to be operated by and under quasi-continuous supervision of qualified medical staff in an appropriate licensed health care facility.

Source page: https://510kreport.com/device/K062265
Methodology: https://510kreport.com/methodology