IZQ — Injector, Contrast Medium, Automatic Class II
FDA Device Classification
Classification Details
- Product Code
- IZQ
- Device Class
- Class II
- Regulation Number
- 870.1650
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252281 | ulrich gmbh and co. kg | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheas | November 18, 2025 |
| K251295 | ulrich gmbh and co. kg | ulrichINJECT CT Motion (XD 8000) | November 7, 2025 |
| K252689 | imaxeon pty | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Pa | September 24, 2025 |
| K241849 | imaxeon pty | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Pa | November 5, 2024 |
| K241850 | ulrich gmbh and co. kg | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheas | August 26, 2024 |
| K233737 | ulrich gmbh and co. kg | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheas | April 19, 2024 |
| K210541 | ulrich gmbh and co. kg | ulrichINJECT CT motion | August 6, 2021 |
| K192872 | ulrich gmbh and co. kg | ulrichINJECT CT Motion | July 2, 2020 |
| K171392 | ulrich gmbh and co. kg | ulrichINJECT CT motion | November 9, 2017 |
| K151048 | bracco injeneering | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP | January 22, 2016 |
| K152361 | liebel-flarsheim company | OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspens | January 14, 2016 |
| K091734 | nemoto kyorindo co | SONIC SHOT GX | May 21, 2010 |
| K063503 | mallinckrodt inc., liebel-flarsheim business | OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION | April 27, 2007 |
| K062449 | e-z-em | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 | April 13, 2007 |
| K063090 | medrad | MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY | March 27, 2007 |
| K062265 | swiss medical care | CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM | December 26, 2006 |
| K031571 | e-z-em | EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 | June 19, 2003 |
| K983314 | nycomed amersham imaging | PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM | February 19, 1999 |
| K984058 | acist medical systems | ACIST INJECTOR SYSTEM, MODEL CL100 H | February 11, 1999 |
| K951005 | kenex | KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) | May 4, 1995 |