The following data is part of a premarket notification filed by Iray Technology (shanghai) Ltd. with the FDA for Wireless Digital Flat Panel Detector.
| Device ID | K161730 |
| 510k Number | K161730 |
| Device Name: | Wireless Digital Flat Panel Detector |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | IRAY TECHNOLOGY (SHANGHAI) LTD. ROOM 202, BUILDING 7, NO. 590, RUIQING ROAD Shanghai, CN 201201 |
| Contact | Wei Pan |
| Correspondent | Wei Pan IRAY TECHNOLOGY (SHANGHAI) LTD. ROOM 202, BUILDING 7, NO. 590, RUIQING ROAD Shanghai, CN 201201 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-23 |
| Decision Date | 2016-12-08 |
| Summary: | summary |