The following data is part of a premarket notification filed by Ge Hangwei Medical Systems, Co., Ltd. with the FDA for Auto Positioning.
| Device ID | K192956 |
| 510k Number | K192956 |
| Device Name: | Auto Positioning |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE Hangwei Medical Systems, Co., Ltd. West Area Of Building No.3, No.1 Yongchang North Road Beijing, CN 100176 |
| Contact | Yonghui Han |
| Correspondent | Yonghui Han GE Hangwei Medical Systems, Co., Ltd. West Area Of Building No.3, No.1 Yongchang North Road 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 | 2019-10-21 |
| Decision Date | 2020-01-16 |