The following data is part of a premarket notification filed by Ge Hangwei Medical System Co., Ltd with the FDA for Smartview 3d Option.
| Device ID | K153429 |
| 510k Number | K153429 |
| Device Name: | SmartView 3D Option |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE HANGWEI MEDICAL SYSTEM CO., LTD NO.1, YONG CHANG STREET, BEIJING ECONOMIC & TECHNICAL DEVELOPMENT AREA Beijing, CN 100176 |
| Contact | Lv Rui |
| Correspondent | Lv Rui GE HANGWEI MEDICAL SYSTEM CO., LTD NO.1, YONG CHANG STREET, BEIJING ECONOMIC & TECHNICAL DEVELOPMENT AREA Beijing, CN 100176 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-25 |
| Decision Date | 2016-03-09 |
| Summary: | summary |