# K983314: Premica CT Contrast Media Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Nycomed Amersham Imaging
- Decided: Feb 19, 1999 after 151 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: 1 generation back to K934086 (1995). 1 ancestor in all.
11 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)
- K934086: Medrad Envision CT Injector and Qwik Fit Syringe, Medrad, Inc. (1995) Summary page 1.

## Most influential descendants
- K062265: CT Expres Iii Contrast Media Delivery System (2006), 10 descendants of its own
- 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

## Indications for use
The Premica™-CT Contrast Media Delivery System is indicated for the controlled automatic administration, on the venous side, of contrast media (CM) for computed tomography scan. The System consists of the Premica™-CT instrument, the Bottle Spike, the Day Set, the Patient Set, and accessories. The System is not intended for injection of CM for coronary arteriography, or for any other use for which the device is not indicated. The Premica™-CT Contrast Media Delivery System is not intended for use with children under 16 years of age.

Source page: https://510kreport.com/device/K983314
Methodology: https://510kreport.com/methodology