The following data is part of a premarket notification filed by Ge Hualun Medical Systems Co., Ltd with the FDA for Discovery Xr656 Hd With Volumerad.
| Device ID | K191699 |
| 510k Number | K191699 |
| Device Name: | Discovery XR656 HD With VolumeRad |
| 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 | Chris Paulik |
| Correspondent | Chris Paulik GE Hualun Medical Systems Co., Ltd No. 1 Yong Chang North Road, Economic Technological Development Zone Beijing, CN 100176 |
| Product Code | KPR |
| Subsequent Product Code | IZF |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-25 |
| Decision Date | 2019-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682146555 | K191699 | 000 |
| 00195278118356 | K191699 | 000 |
| 00195278070265 | K191699 | 000 |