The following data is part of a premarket notification filed by Ge Hualun Medical Systems Co.ltd. with the FDA for Discovery Xr656 Hd.
| Device ID | K172869 |
| 510k Number | K172869 |
| Device Name: | Discovery XR656 HD |
| Classification | System, X-ray, Stationary |
| Applicant | GE Hualun Medical Systems Co.Ltd. No.1 YongChang North Road, Beijing Economic Technological Development Zone Beijing, CN 100176 |
| Contact | Kenny Ma |
| Correspondent | Kenny Ma GE Hualun Medical Systems Co.Ltd. No.1 YongChang North Road, Beijing 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 | 2017-09-20 |
| Decision Date | 2017-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682121071 | K172869 | 000 |
| 00840682138598 | K172869 | 000 |
| 00840682136709 | K172869 | 000 |