The following data is part of a premarket notification filed by Jiangsu Rayer Medical Technology Co., Ltd. with the FDA for Image Guidance System For Radiotherapy.
| Device ID | K192405 |
| 510k Number | K192405 |
| Device Name: | Image Guidance System For Radiotherapy |
| Classification | Accelerator, Linear, Medical |
| Applicant | Jiangsu Rayer Medical Technology Co., Ltd. Xishan Economic Development Zone Wuxi, CN 214192 |
| Contact | Peng Li |
| Correspondent | Peng Li Jiangsu Rayer Medical Technology Co., Ltd. No. 99 Furongzhongsan Road, Xishan Ecomic Development Zone Wuxi, CN 214192 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-03 |
| Decision Date | 2020-05-01 |