IZQ
- Product code
- IZQ
- Device name
- Injector, Contrast Medium, Automatic
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1650
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 23
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262115 | 2026-08-03 | ACIST Medical Systems, Inc. | VueJect® Ultrasound Enhancing Agent Delivery System | |
| K252281 | 2025-11-18 | Ulrich GmbH & Co. KG | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT | |
| K251295 | 2025-11-07 | Ulrich GmbH & Co. KG | ulrichINJECT CT Motion (XD 8000) | |
| K252689 | 2025-09-24 | Imaxeon Pty, Ltd. | MEDRAD Centargo CT Injection System; MEDRAD Centargo | |
| K241849 | 2024-11-05 | Imaxeon Pty, Ltd. | MEDRAD Centargo CT Injection System; MEDRAD Centargo | |
| K241850 | 2024-08-26 | Ulrich GmbH & Co. KG | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT | |
| K233737 | 2024-04-19 | Ulrich GmbH & Co. KG | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT |
Official FDA classification page: IZQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).