# IZQ: Injector, Contrast Medium, Automatic

- Device class: 2; regulation: 21 CFR 870.1650; FDA's rule: 510(k) required
- FDA decisions: 23
- 510(k) review time 2021–2025: median 131 days (middle half 90–156)
- Recalls: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2006: 1
- 2007: 3
- 2010: 1
- 2016: 2
- 2017: 1
- 2020: 1
- 2021: 1
- 2024: 3
- 2025: 3
- 2026: 1

## Most-cited predicates
- K151048: CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set (2016), cited by 2
- K063503: Optivantage DH Injector System with Enhanced Communication (2007), cited by 2
- K192872: ulrichINJECT CT Motion (2020), cited by 2
- K063090: Medrad Stellant CT Injector System with XDS Accessory (2007), cited by 2
- K031571: Empowercta Injector System, Models 9930 & 9910 & 9825 (2003), cited by 2
- 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
- K233737: ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (2024), cited by 1
- K984058: Acist Injector System, Model CL100 H (1999), cited by 1
- K983314: Premica CT Contrast Media Delivery System (1999), cited by 1
- K210541: ulrichINJECT CT motion (2021), cited by 1

Source page: https://510kreport.com/product-code/IZQ
Data by year (CSV): https://510kreport.com/product-code/IZQ.csv