Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Iray Technology Taicang , Ltd. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
110 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223010 | Portable X-ray System | Iray Technology Taicang , Ltd. | 2023-01-17 | 110 | 0 |
| K222886 | Mercu 1717V | Iray Technology Taicang , Ltd. | 2022-10-20 | 27 | 0 |
| K221714 | Flat Panel Detector | Iray Technology Taicang , Ltd. | 2022-06-29 | 16 | 0 |
| K221345 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | 2022-06-16 | 38 | 0 |
| K220536 | Digital flat panel detector | Iray Technology Taicang , Ltd. | 2022-04-28 | 63 | 0 |
| K220668 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | 2022-04-01 | 25 | 0 |
| K213529 | Focus HD 43 Detector | Iray Technology Taicang , Ltd. | 2022-03-29 | 145 | 0 |
| K213646 | Focus HD 35 Detector | Iray Technology Taicang , Ltd. | 2022-03-29 | 145 | 0 |
| K220422 | Dental sensors NanoPix1, NanoPix2 | Iray Technology Taicang , Ltd. | 2022-03-11 | 25 | 0 |
| K212279 | Digital Intraoral X-ray Imaging System | Iray Technology Taicang , Ltd. | 2021-10-07 | 79 | 0 |
| K210312 | PlutoX Digital Intraoral X-Ray Imaging System | Iray Technology Taicang , Ltd. | 2021-04-23 | 79 | 0 |
| K210316 | Mars 1417X Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | 2021-03-03 | 28 | 0 |
| K210314 | Mars1717X Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | 2021-03-02 | 27 | 0 |
| K201043 | Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, | Iray Technology Taicang , Ltd. | 2020-05-12 | 22 | 0 |
| K201004 | Wireless Digital Flat Panel Detector Model Name Mars1417V-TS | Iray Technology Taicang , Ltd. | 2020-05-01 | 15 | 0 |
| K200622 | Focus 43C detector, TRIMAX 43C detector | Iray Technology Taicang , Ltd. | 2020-04-01 | 23 | 0 |
| K192512 | Focus 35C Detector, Trimax 35C Detector | Iray Technology Taicang , Ltd. | 2019-10-16 | 34 | 0 |
| K183422 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | 2019-01-09 | 30 | 0 |
| K183713 | Wireless Digital Flat Detector | Iray Technology Taicang , Ltd. | 2019-01-09 | 30 | 0 |
| K182550 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | 2018-10-17 | 30 | 0 |
| K182551 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | 2018-10-17 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda