Dual Shot Alpha 7
The Dual Shot Alpha 7 delivers contrast media and saline during computed tomography examinations. Licensed medical practitioners use this dual-syringe injector with multislice CT scanners,…
The Dual Shot Alpha 7 delivers contrast media and saline during computed tomography examinations. Licensed medical practitioners use this dual-syringe injector with multislice CT scanners, with each of its two drive mechanisms accepting a 100 mL or 200 mL syringe.
Electromechanical actuators on the injector head drive the syringes, which connect to the patient through an intravascular catheter. The touchscreen console lets the operator set injection pressure, time, volume and flow rate and view the injection parameters.
Listed Item
Nemoto DUAL SHOT alpha 7 contrast delivery system for CT applications.
Injection Controls
Controls on the injector head provide manual operation and start and stop functions. The head detects injection conditions and reports its status to the console; an optional hand switch can start or stop a preset protocol.
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (3), Shandong (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 15 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Jiangxi Baoeran Biomedical Science & Technology Co., Ltd. | Fuzhou | Jiangxi | Contract manufacturer | 1 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Shandong INT Medical Instruments Co., Ltd. | Rizhao | Shandong | Manufacturer | 4 |
| Zhuhai DR Medical Instruments Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 4 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Showing 12 of 15. All 15 manufacturers in China registered for Injector And Syringe, Angiographic
Record
| Listed by | Nemoto Kyorindo Co., Ltd., Japan |
|---|---|
| FDA product code | DXT |
| Device type | Injector And Syringe, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Manufacturer |
| 510(k) | K133189 |
| Record published | 2016-07-15 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 5 to 95 % RH; Storage environment temperature -40 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 170 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sinton Medical Products | Shenzhen Boon Medical Supply Co., Ltd. | 199 |
| DeRoyal | Deroyal Industries, Inc. | 138 |
| Antmed | Shenzhen Antmed Co., Ltd. | 91 |
| Medline Industries, Inc. | Medline Industries, Inc. | 59 |
| LF | Liebel-Flarsheim Company LLC | 58 |
| Namic | Medline Industries, Inc. | 50 |
| Merit Medical® | Merit Medical Systems, Inc. | 46 |
| Medical Imaging Solutions International | Shenzhen Boon Medical Supply Co., Ltd. | 43 |
| LF | Shenzhen Boon Medical Supply Co., Ltd. | 38 |
| Namic | Navilyst Medical, Inc. | 38 |
| Coeur | Coeur, Inc. | 38 |
| Medical Imaging Solutions Intl. | Medical Imaging Solutions, Inc. | 37 |
Showing 12 of 168. All products under Injector And Syringe, Angiographic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242212 | 2024-08-27 |
| K173450 | 2018-02-07 |
| K133189 | 2014-06-30 |
| K092896 | 2010-10-29 |
| K071691 | 2007-12-19 |
| K062168 | 2006-08-18 |
| K052633 | 2005-10-17 |
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.