Iray Technology Taicang , Ltd.: FDA clearances and approvals
Iray Technology Taicang , Ltd. has 21 FDA 510(k) clearances (first 2018, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time: 30 days. Since 2017 its median was 30 days, against 51 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 2 | 30 |
| 2019 | 3 | 30 |
| 2020 | 3 | 22 |
| 2021 | 4 | 54 |
| 2022 | 8 | 32 |
| 2023 | 1 | 110 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Iray Technology Taicang , Ltd.'s cleared 510(k)s took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 51 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 17 | 17 |
| MUH | System, X-Ray, Extraoral Source, Digital | 3 | 3 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
Review panels
- Radiology (21)
Most recent Iray Technology Taicang , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223010 | Portable X-ray System | EHD | 2023-01-17 | 110 |
| K222886 | Mercu 1717V | MQB | 2022-10-20 | 27 |
| K221714 | Flat Panel Detector | MQB | 2022-06-29 | 16 |
| K221345 | Wireless Digital Flat Panel Detector | MQB | 2022-06-16 | 38 |
| K220536 | Digital flat panel detector | MQB | 2022-04-28 | 63 |
| K220668 | Wireless Digital Flat Panel Detector | MQB | 2022-04-01 | 25 |
| K213646 | Focus HD 35 Detector | MQB | 2022-03-29 | 145 |
| K213529 | Focus HD 43 Detector | MQB | 2022-03-29 | 145 |
| K220422 | Dental sensors NanoPix1, NanoPix2 | MUH | 2022-03-11 | 25 |
| K212279 | Digital Intraoral X-ray Imaging System | MUH | 2021-10-07 | 79 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Iray Technology Taicang , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Iray Technology Taicang , Ltd. have?
Iray Technology Taicang , Ltd. has 21 FDA 510(k) clearances (first 2018, latest 2023), across 3 product codes in 1 review panel.
How long does FDA take to clear Iray Technology Taicang , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Iray Technology Taicang , Ltd.'s cleared 510(k)s is 30 days. Since 2017: 30 days, versus 51 days for all cleared 510(k)s in the same product codes.
What devices does Iray Technology Taicang , Ltd. make?
Its most frequent FDA product codes are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 17); MUH (System, X-Ray, Extraoral Source, Digital, 3); EHD (Unit, X-Ray, Extraoral With Timer, 1).
Has Iray Technology Taicang , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Iray Technology Taicang , Ltd. Related entities may recall under other names.
Next steps
- See all 21 Iray Technology Taicang , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MQB, Iray Technology Taicang , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.