510(k) · Cleared
ClearedMEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaxeon Pty, Ltd. · IZQ Injector, Contrast Medium, Automatic
Cleared on Sep 24, 2025 as substantially equivalent to K241849 (Imaxeon Pty, Ltd., 2024) after a 29-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Sep 24, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- IZQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K934086 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- 4 generations backK983314 Premica CT Contrast Media Delivery SystemNycomed Amersham Imaging · 1999
- 3 generations backK062265 CT Expres Iii Contrast Media Delivery SystemSwiss Medical Care S.A. · 2006
- 2 generations backK151048 CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B…Bracco Injeneering · 2016
- 1 generation backK241849 MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD…Imaxeon Pty, Ltd. · 2024
- This deviceK252689 MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD…Imaxeon Pty, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| −4 | K983314 | Premica CT Contrast Media Delivery System | Nycomed Amersham Imaging | 1999 | — |
| −3 | K062265 | CT Expres Iii Contrast Media Delivery System | Swiss Medical Care S.A. | 2006 | — |
| −2 | K151048 | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III… | Bracco Injeneering | 2016 | — |
| −1 | K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo… | Imaxeon Pty, Ltd. | 2024 | — |
| 0 (this device) | K252689 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo… | Imaxeon Pty, Ltd. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IZQ device
- #1 K241850 ulricheasyINJECT Max 2M (XD 10140)…score 12.7 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient…Summary page 5…II Product Code: IZQ III. PREDICATE DEVICE Trade Name: MEDRAD® Centargo CT Injection System 510(k) Number: K241849 Common Name: Automatic injector for contrast media Classification Name: Injector, Contrast Medium… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 7.8 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All IZQ devicesIZQ Injector, Contrast Medium, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · IZQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZQ
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZQ
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZQ
21in 2025
MAUDE reports naming product code IZQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 168 | 0 | 14 |
| 2008 | 0 | — | 1 | 72 |
| 2009 | 0 | — | 0 | 48 |
| 2010 | 1 | — | 0 | 42 |
| 2011 | 0 | — | 2 | 41 |
| 2012 | 0 | — | 0 | 23 |
| 2013 | 0 | — | 0 | 23 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 1 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 3 | 131 | 0 | 23 |
| 2025 | 3 | 119 | 0 | 21 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
MEDRAD® Centargo CT Injection System is an automated contrast injection system that is indicated for the controlled, automatic administration, via the venous route, of a contrast agent and 0.9% Sodium Chloride Injection USP (saline) to patients undergoing examinations in computed tomography (CT). The system is intended for use by and under direct quasi-continuous supervision of trained healthcare professionals to assure the integrity of the contrast…
Read the full statement (274 words)
MEDRAD® Centargo CT Injection System is an automated contrast injection system that is indicated for the controlled, automatic administration, via the venous route, of a contrast agent and 0.9% Sodium Chloride Injection USP (saline) to patients undergoing examinations in computed tomography (CT).
The system is intended for use by and under direct quasi-continuous supervision of trained healthcare professionals to assure the integrity of the contrast agent and the injection system, in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
For a complete list of compatible contrast agents for use with the MEDRAD® Centargo CT Injection System, refer to the Centargo CT Injection System Operation Manual.
The Day Set is used for a maximum time of twenty-four (24) hours, or for a maximum of 25 bottles of contrast agents, whichever comes first. The Patient Line must be discarded after each patient procedure. The Replacement Spike is for single-container use only and must be discarded with the fluid container. Contrast agent containers are to be discarded after their respective use times have expired or the Day Set use life has expired, whichever occurs first.
Saline should only be used to deliver multiple single doses to multiple patients when used with the MEDRAD® Centargo CT Injection System and the provided Saline Tag. Once the port of the saline container is punctured, it should not be removed from the work area during the entire period of use. Saline containers are to be discarded with the Day Set.
The ISI2 Module is indicated for the specific purpose of allowing an injector to interface with an imaging scanner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252689 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252689: MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252689
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026