Ul_inject
XD 8000, ulrichINJECT CT motion composed of:
1manufacturer
1catalogue number
7510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
Record
| Listed by | Ulrich Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | IZQ |
| Device type | Injector, Contrast Medium, Automatic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K171392 |
| Record published | 2019-03-12 |
| Record revised | 2022-04-29 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XD 8000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LF | Liebel-Flarsheim Company LLC | 16 |
| ulrich medical disposables | Ulrich Gmbh & Co. KG | 9 |
| Injector, Contrast Medium, Automatic | Ulrich Gmbh & Co. KG | 5 |
| ulricheasyINJECT Max | Ulrich Gmbh & Co. KG | 3 |
| Remote Control | Bracco Injeneering | 3 |
| Floor Stand | Bracco Injeneering | 3 |
| FastLoad™ MR Syringe Pack | Bracco Injeneering | 3 |
| EmpowerCTA®+ Injector System | Bracco Injeneering | 3 |
| Medrad® Stellant Flex Syringe Kit | Bayer Medical Care Inc. | 3 |
| Hydraulic Controller | Bracco Injeneering | 2 |
| Day Set III HP | Bracco Injeneering | 2 |
| EmpowerMR® Injector System without Remote Control | Bracco Injeneering | 2 |
Showing 12 of 38. All products under Injector, Contrast Medium, Automatic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252281 | 2025-11-18 |
| K251295 | 2025-11-07 |
| K241850 | 2024-08-26 |
| K233737 | 2024-04-19 |
| K210541 | 2021-08-06 |
| K192872 | 2020-07-02 |
| K171392 | 2017-11-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.