EHD
- Product code
- EHD
- Device name
- Unit, X-Ray, Extraoral With Timer
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.1800
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 16
- Summaries archived here
- 11 (direct download)
- 510(k) clearances (all years, FDA)
- 190 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (16)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260367 | 2026-05-27 | PDX Co., Ltd. | Portable Dental X-ray System Model PDX nova | FDA |
| K253864 | 2026-03-20 | Dental Imaging Technologies Corporatio… | NOMAD Pro 3 | |
| K252110 | 2026-03-12 | Guangzhou Ajax Medical Equipment Co., … | Dental X-RAY Unit (AJX200) | |
| K254018 | 2026-02-19 | Guilin Refine Medical Instrument Co., … | Portable Dental X-ray Device (GT-1) | |
| K252909 | 2026-02-03 | Ningbo Runyes Medical Instrument Co., … | Diagnostic X-Ray Equipment Model POCT22 | |
| K251438 | 2025-09-04 | Guilin Woodpecker Medical Instrument C… | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master… | |
| K242185 | 2024-12-04 | Raypia Co., Ltd. | Rextar Pro | |
| K242591 | 2024-11-01 | DRTECH Corporation | XERO-alpha | |
| K241963 | 2024-07-30 | Picopack Co., Ltd. | WERAY | FDA |
| K241305 | 2024-07-05 | Lucas Lifecare | LifeRay Intraoral Handheld X-ray System | FDA |
| K240759 | 2024-05-13 | Remedi Co., Ltd. | REMEX-GR100 | — |
| K233914 | 2024-02-08 | Shenzhen Xpectvision Technology Co., L… | XVbeam2000 | |
| K233395 | 2024-01-03 | Alliage S/A Industrias Médico Odontoló… | Portable Dental X-Ray (AXR60 S); Portable Dental X-… | FDA |
| K231055 | 2023-12-28 | De Götzen S.R.L. | x-mind dc (under trademark Acteon), Owandy-RX DC (un… | |
| K232085 | 2023-12-08 | Genoray Co., Ltd. | DVAS (DVAS-M, DVAS-W) | |
| K232012 | 2023-11-28 | Osstem Implant Co., Ltd. | N1 |
Official FDA classification page: EHD
Classification and pathway per current FDA publications. Data from openFDA (CC0).