# Imaxeon Pty, Ltd.

- Location (FDA's records): Rydalmere, AU
- FDA decisions: 2 (2024–2025): 2 510(k) clearances
- Product codes: IZQ (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bracco Injeneering: 1 (https://510kreport.com/company/bracco-injeneering)

## Its most-cited devices
- K241849: MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) (2024), cited by 1

## Recent decisions
- K252689: MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) (Sep 24, 2025)
- K241849: MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) (Nov 5, 2024)

Source page: https://510kreport.com/company/imaxeon