Iray Technology Taicang , Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 21
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K223010 | Portable X-ray System | January 17, 2023 |
| K222886 | Mercu 1717V | October 20, 2022 |
| K221714 | Flat Panel Detector | June 29, 2022 |
| K221345 | Wireless Digital Flat Panel Detector | June 16, 2022 |
| K220536 | Digital flat panel detector | April 28, 2022 |
| K220668 | Wireless Digital Flat Panel Detector | April 1, 2022 |
| K213529 | Focus HD 43 Detector | March 29, 2022 |
| K213646 | Focus HD 35 Detector | March 29, 2022 |
| K220422 | Dental sensors NanoPix1, NanoPix2 | March 11, 2022 |
| K212279 | Digital Intraoral X-ray Imaging System | October 7, 2021 |
| K210312 | PlutoX Digital Intraoral X-Ray Imaging System | April 23, 2021 |
| K210316 | Mars 1417X Wireless Digital Flat Panel Detector | March 3, 2021 |
| K210314 | Mars1717X Wireless Digital Flat Panel Detector | March 2, 2021 |
| K201043 | Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) | May 12, 2020 |
| K201004 | Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector | May 1, 2020 |
| K200622 | Focus 43C detector, TRIMAX 43C detector | April 1, 2020 |
| K192512 | Focus 35C Detector, Trimax 35C Detector | October 16, 2019 |
| K183713 | Wireless Digital Flat Detector | January 9, 2019 |
| K183422 | Wireless Digital Flat Panel Detector | January 9, 2019 |
| K182551 | Wireless Digital Flat Panel Detector | October 17, 2018 |