FDA device listing
MEDRAD Centargo CT Injection System,MEDRAD Centargo Day Set,MEDRAD Centargo Patient Line,MEDRAD Centargo Replacement…
FDA device listing 1193200262 · Imaxeon Pty Ltd
Key facts
| Proprietary names | MEDRAD Centargo CT Injection System,MEDRAD Centargo Day Set,MEDRAD Centargo Patient Line,MEDRAD Centargo Replacement Spike,MEDRAD ISI2 Module (ISI2) |
|---|---|
| Owner/operator | Imaxeon Pty Ltd |
| Owner/operator number | 10092112 |
| Premarket submissions | K252689 |
| Product codes | IZQ |
| Device names | IZQ - Injector, Contrast Medium, Automatic |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1650 |
| Review panels | Cardiovascular |
| Registered establishments | IMAXEON PTY LTD |
| Establishment registrations | 3003786696 |
| FEI numbers | 3003786696 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database