Hydraulic Controller
2 catalogue numbers from 017378, listed by Bracco Injeneering, Switzerland, under Injector, Contrast Medium, Automatic. 1 manufacturer in China is registered for this product code.
1manufacturer
2catalogue numbers in this listing
1510(k) clearance
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 | Bracco Injeneering, Switzerland |
|---|---|
| FDA product code | IZQ |
| Device type | Injector, Contrast Medium, Automatic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| 510(k) | K062449 |
| Record published | 2016-09-20 |
| Record revised | 2024-04-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Special storage condition: Dry environment |
| Packaging | Box |
| Distribution end date | 2016-09-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 017378 | In distribution | |
| 017378 | Withdrawn |
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 |
| Day Set III HP | Bracco Injeneering | 2 |
| EmpowerMR® Injector System without Remote Control | Bracco Injeneering | 2 |
| Medrad XDS Extravasation Detection System | Bayer Medical Care Inc. | 2 |
Showing 12 of 38. All products under Injector, Contrast Medium, Automatic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151048 | 2016-01-22 |
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.