The following data is part of a premarket notification filed by Iray Technology Taicang Ltd. with the FDA for Mercu 1717v.
| Device ID | K222886 |
| 510k Number | K222886 |
| Device Name: | Mercu 1717V |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | iRay Technology Taicang Ltd. No. 33 Xinggang Rd., Taicang Port Economic Technological Development Zone Taicang, CN 215434 |
| Contact | Junjie Qian |
| Correspondent | Junjie Qian iRay Technology Taicang Ltd. No. 33 Xinggang Rd., Taicang Port Economic Technological Development Zone Taicang, CN 215434 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-23 |
| Decision Date | 2022-10-20 |