Device Listing 1327165487

Listing Summary#

Listing key
1327165487
Premarket submission
K252689
Device
MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
Applicant
Imaxeon Pty, Ltd.
Product code
IZQ
Decision date
2025-09-24