Iray Technology Taicang, Ltd.
Taicang, CN
Iray Technology Taicang , Ltd. appears in FDA device records in Taicang, CN. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Iray Technology Taicang, Ltd. between 2018 and 2023. The busiest year on record is 2022, with 8. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 3 |
| 2021 | 4 |
| 2022 | 8 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223010 | Portable X-ray System | EHD | Substantially Equivalent | |
| K222886 | Mercu 1717V | MQB | Substantially Equivalent | |
| K221714 | Flat Panel Detector | MQB | Substantially Equivalent | |
| K221345 | Wireless Digital Flat Panel Detector | MQB | Substantially Equivalent | |
| K220536 | Digital flat panel detector | MQB | Substantially Equivalent | |
| K220668 | Wireless Digital Flat Panel Detector | MQB | Substantially Equivalent | |
| K213646 | Focus HD 35 Detector | MQB | Substantially Equivalent | |
| K213529 | Focus HD 43 Detector | MQB | Substantially Equivalent | |
| K220422 | Dental sensors NanoPix1, NanoPix2 | MUH | Substantially Equivalent | |
| K212279 | Digital Intraoral X-ray Imaging System | MUH | Substantially Equivalent | |
| K210312 | PlutoX Digital Intraoral X-Ray Imaging System | MUH | Substantially Equivalent | |
| K210316 | Mars 1417X Wireless Digital Flat Panel Detector | MQB | Substantially Equivalent | |
| K210314 | Mars1717X Wireless Digital Flat Panel Detector | MQB | Substantially Equivalent | |
| K201043 | Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) | MQB | Substantially Equivalent | |
| K201004 | Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W | MQB | Substantially Equivalent | |
| K200622 | Focus 43C detector, TRIMAX 43C detector | MQB | Substantially Equivalent | |
| K192512 | Focus 35C Detector, Trimax 35C Detector | MQB | Substantially Equivalent | |
| K183713 | Wireless Digital Flat Detector | MQB | Substantially Equivalent | |
| K183422 | Wireless Digital Flat Panel Detector | MQB | Substantially Equivalent | |
| K182551 | Wireless Digital Flat Panel Detector | MQB | Substantially Equivalent | |
| K182550 | Wireless Digital Flat Panel Detector | MQB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain