Portable Dental X-ray System Model PDX nova
FDA 510(k) K260367 · PDX Co., Ltd.
510(k) numberK260367
Submission
- Device name
- Portable Dental X-ray System Model PDX nova
- Applicant
- PDX Co., Ltd.
Anyang-Si, Gyeonggi-Do, CN - Received
- February 4, 2026
- Decision date
- May 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EHD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )EHD · Special | Guilin Woodpecker Medical Instrument Co., Ltd. | 09/04/2025SE |
| 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 |
Questions and answers
When was Portable Dental X-ray System Model PDX nova cleared by the FDA?
Portable Dental X-ray System Model PDX nova (K260367) received a 510(k) decision of Substantially Equivalent on May 27, 2026, 112 days after the submission was received.
What is the product code of K260367?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.