The following data is part of a premarket notification filed by Iray Technology Taicang Ltd. with the FDA for Focus 35c Detector, Trimax 35c Detector.
| Device ID | K192512 |
| 510k Number | K192512 |
| Device Name: | Focus 35C Detector, Trimax 35C Detector |
| 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 | Meng Li |
| Correspondent | Meng Li 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 | 2019-09-12 |
| Decision Date | 2019-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889976702345 | K192512 | 000 |