Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
FDA 510(k) K251438 · Guilin Woodpecker Medical Instrument Co., Ltd.
510(k) numberK251438
Submission
- Device name
- Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
- Applicant
- Guilin Woodpecker Medical Instrument Co., Ltd.
Guilin, CN - Received
- May 9, 2025
- Decision date
- September 4, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EHD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260367 | Portable Dental X-ray System Model PDX novaEHD · Traditional | PDX Co., Ltd. | 05/27/2026SE |
| K253864 | NOMAD Pro 3EHD · Traditional | Dental Imaging Technologies Corporation | 03/20/2026SE |
| K252110 | Dental X-RAY Unit (AJX200)EHD · Traditional | Guangzhou Ajax Medical Equipment Co., Ltd. | 03/12/2026SE |
| K254018 | Portable Dental X-ray Device (GT-1)EHD · Traditional | Guilin Refine Medical Instrument Co., Ltd. | 02/19/2026SE |
| K252909 | Diagnostic X-Ray Equipment Model POCT22EHD · Traditional | Ningbo Runyes Medical Instrument Co., Ltd. | 02/03/2026SE |
| K242185 | Rextar ProEHD · Traditional | Raypia Co., Ltd. | 12/04/2024SE |
| K242591 | XERO-alphaEHD · Traditional | DRTECH Corporation | 11/01/2024SE |
| K241963 | WerayEHD · Traditional | Picopack Co., Ltd. | 07/30/2024SE |
| K241305 | LifeRay Intraoral Handheld X-ray SystemEHD · Traditional | Lucas Lifecare | 07/05/2024SE |
| K240759 | REMEX-GR100EHD · Traditional | Remedi Co., Ltd. | 05/13/2024SE |
More from Remedi Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K222569 | Ai Ray Dental X-Ray DeviceEHD · Traditional | 11/23/2022SE |
| K211358 | Implanter incl. AccessoriesEBW · Traditional | 11/21/2022SE |
| K221548 | Dental Air Polishing HandpieceEFB · Traditional | 09/28/2022SE |
| K210367 | D-Laser Blue, D-Laser 16NVK · Traditional | 03/10/2022SE |
| K203706 | Dental Electric MotorEBW · Traditional | 01/13/2022SE |
| K211531 | Cordless Prophy System, Model: i-PolishEKX · Traditional | 12/17/2021SE |
| K203615 | Dental Scaler and Air PolisherELC · Traditional | 12/10/2021SE |
| K212080 | Imaging Plate Scanner, i-ScanMUH · Traditional | 09/27/2021SE |
| K203320 | Endo MotorEKX · Traditional | 05/10/2021SE |
| K181087 | Apex Locator, DPEX IIILQY · Traditional | 12/18/2018SE |
Questions and answers
When was Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) cleared by the FDA?
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (K251438) received a 510(k) decision of Substantially Equivalent on September 4, 2025, 118 days after the submission was received.
What is the product code of K251438?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.