FDA product code IZQ: Injector, Contrast Medium, Automatic
IZQ is the FDA product code for injector, contrast medium, automatic. It is a Class II device, regulated under 21 CFR 870.1650 and reviewed by the General Hospital panel. FDA has cleared 23 510(k) submissions under IZQ, 7 in the last five years, from 14 different applicants. The average 510(k) review took 139 days (median 147); 90 days on average over the last three years. FDA has posted 3 recalls for IZQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Injector, Contrast Medium, Automatic |
| Device class | Class II |
| Regulation | 21 CFR 870.1650 |
| Review panel | HO — General Hospital |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for IZQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 182 |
| 2020 | 1 | 268 |
| 2021 | 1 | 163 |
| 2024 | 3 | 113 |
| 2025 | 3 | 115 |
| 2026 | 1 | 41 |
Compare with all 510(k) review times · Search every IZQ clearance
Top IZQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ulrich GmbH & Co. KG | 7 | 2025-11-18 |
| Imaxeon Pty, Ltd. | 2 | 2025-09-24 |
| E-Z-Em, Inc. | 2 | 2007-04-13 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 1976-10-08 |
| ACIST Medical Systems, Inc. | 1 | 2026-08-03 |
9 more applicants have IZQ clearances. See the full list in Caduvo.
Most recent IZQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262115 | ACIST Medical Systems, Inc. | VueJect® Ultrasound Enhancing Agent Delivery System | 2026-08-03 | 41 |
| K252281 | Ulrich GmbH & Co. KG | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | 2025-11-18 | 119 |
| K251295 | Ulrich GmbH & Co. KG | ulrichINJECT CT Motion (XD 8000) | 2025-11-07 | 196 |
| K252689 | Imaxeon Pty, Ltd. | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | 2025-09-24 | 29 |
| K241849 | Imaxeon Pty, Ltd. | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | 2024-11-05 | 131 |
Recalls for IZQ devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-10-11.
Frequently asked questions
What is FDA product code IZQ?
IZQ is the FDA product code for injector, contrast medium, automatic. It is a Class II device, regulated under 21 CFR 870.1650 and reviewed by the General Hospital panel.
What device class is IZQ?
Class II, regulation 21 CFR 870.1650. Typical premarket route: 510(k).
How long does a 510(k) take for product code IZQ?
Across 23 cleared submissions the average was 139 days from receipt to decision (median 147).
Which companies have the most IZQ clearances?
Ulrich GmbH & Co. KG (7); Imaxeon Pty, Ltd. (2); E-Z-Em, Inc. (2); Bd Becton Dickinson Vacutainer Systems Preanalytic (2); ACIST Medical Systems, Inc. (1).
Have IZQ devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2011-10-11.
Next steps
- Run an FDA pathway report with predicate devices for product code IZQ
- Run a recall and safety report across every IZQ manufacturer
- Watch product code IZQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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