The following data is part of a premarket notification filed by Ge Hualun Medical Systems Co., Ltd with the FDA for Optima Xr646 Hd.
| Device ID | K173612 |
| 510k Number | K173612 |
| Device Name: | Optima XR646 HD |
| Classification | System, X-ray, Stationary |
| Applicant | GE Hualun Medical Systems Co., Ltd No.1 Yong Chang North Road, Economic Technological Development Zone Beijing, CN 100176 |
| Contact | Kenny Ma |
| Correspondent | Kenny Ma GE Hualun Medical Systems Co., Ltd. No.1 Yong Chang North Road, Economic Technological Development Zone Beijing, CN 100176 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-22 |
| Decision Date | 2017-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682142175 | K173612 | 000 |
| 00840682142168 | K173612 | 000 |