Product code EHD
- Device name
- Unit, X-Ray, Extraoral With Timer
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.1800
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253864 | NOMAD Pro 3 | Dental Imaging Technologies Corporation | 2026-03-20 |
| K252110 | Dental X-RAY Unit (AJX200) | Guangzhou Ajax Medical Equipment Co., Ltd. | 2026-03-12 |
| K254018 | Portable Dental X-ray Device (GT-1) | Guilin Refine Medical Instrument Co., Ltd. | 2026-02-19 |
| K252909 | Diagnostic X-Ray Equipment Model POCT22 | Ningbo Runyes Medical Instrument Co., Ltd. | 2026-02-03 |
| K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2025-09-04 |
| K242185 | Rextar Pro | Raypia Co., Ltd. | 2024-12-04 |
| K242591 | XERO-alpha | DRTECH Corporation | 2024-11-01 |
| K241963 | WERAY | Picopack Co., Ltd. | 2024-07-30 |
| K241305 | LifeRay Intraoral Handheld X-ray System | Lucas Lifecare | 2024-07-05 |
| K240759 | REMEX-GR100 | Remedi Co., Ltd. | 2024-05-13 |
| K233914 | XVbeam2000 | Shenzhen Xpectvision Technology Co., Ltd. | 2024-02-08 |
| K233395 | Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) | Alliage S/A Industrias Médico Odontológica | 2024-01-03 |
| K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) | De Götzen S.R.L. | 2023-12-28 |
| K232085 | DVAS (DVAS-M, DVAS-W) | Genoray Co., Ltd. | 2023-12-08 |
| K232012 | N1 | Osstem Implant Co., Ltd. | 2023-11-28 |
| K232068 | HyperLight Portable X-ray Unit | Changzhou Sifary Medical Technology Co., Ltd. | 2023-09-01 |
| K231449 | Portable X-ray System Model Ray98(P) | Ningbo Runyes Medical Instrument Co., Ltd. | 2023-07-13 |
| K223780 | Lumos 3DX | 3Dio | 2023-07-06 |
| K221587 | DHX-70H, XTG-70H | Digimed Co., Ltd. | 2023-03-03 |
| K223010 | Portable X-ray System | Iray Technology Taicang , Ltd. | 2023-01-17 |
| K222569 | Ai Ray Dental X-Ray Device | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-11-23 |
| K223058 | EzRay Air 2 Wall (Model: VEX-S350W) | VATECH Co., Ltd. | 2022-10-26 |
| K220579 | Hybrid C70 | Digimed Co., Ltd. | 2022-09-01 |
| K222274 | FONA XDC | Fona S.R.L | 2022-08-23 |
| K221286 | CLAROX | Vsi Co., Ltd. | 2022-06-29 |
| K221233 | DT-703 | Ecotron Co., Ltd. | 2022-06-27 |
| K220574 | HYBRID S70 | Digimed Co., Ltd. | 2022-04-22 |
| K213282 | ERI Handheld Dental X-ray System (Model AG100) | Energy Resources International Co., Ltd. Hsinchu Branch | 2022-04-04 |
| K211014 | Portray | Surround Medical Systems | 2021-07-28 |
| K201800 | Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) | Nanoray Co., Ltd. | 2020-12-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07899581344695 | EVOLVE SENSOR | Alliage S/A Indústrias Médico Odontológica | 2023-12-08 |
| 07899581344701 | EVOLVE SENSOR | Alliage S/A Indústrias Médico Odontológica | 2023-12-08 |
| 07899581340260 | Intraoral Dental Digital Imaging Sensor | Alliage S/A Indústrias Médico Odontológica | 2023-10-18 |
| 07899581340284 | Intraoral Dental Digital Imaging Sensor | Alliage S/A Indústrias Médico Odontológica | 2023-10-18 |
| 07899581340697 | Intraoral Dental Digital Imaging Sensor | Alliage S/A Indústrias Médico Odontológica | 2023-10-18 |
| 07899581340727 | Intraoral Dental Digital Imaging Sensor | Alliage S/A Indústrias Médico Odontológica | 2023-10-18 |
| 07899581340253 | Intraoral Dental Digital Imaging Sensor | Alliage S/A Indústrias Médico Odontológica | 2023-10-18 |
| 08033837931669 | myray | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931768 | Stern Weber | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931676 | myray | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931683 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931690 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931706 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931713 | Anthos | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931720 | Anthos | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931737 | Anthos | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931744 | Stern Weber | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931751 | Stern Weber | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931652 | myray | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931645 | myray | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931638 | myray | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931621 | myray | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931591 | Castellini | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931584 | Stern Weber | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931577 | Anthos | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931560 | myray | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931553 | myray | CEFLA SOCIETA' COOPERATIVA | 2017-08-31 |
| 08033837931607 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2017-08-03 |
| 08033837931423 | myray | CEFLA SOCIETA' COOPERATIVA | 2016-10-03 |
| 08033837930136 | myray | CEFLA SOCIETA' COOPERATIVA | 2016-10-03 |