IZQ — Injector, Contrast Medium, Automatic Class II
FDA product code IZQ covers "Injector, Contrast Medium, Automatic", a Class II medical device regulated under 21 CFR 870.1650. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |