Dental X-RAY Unit (AJX200)— 510(k) K252110
Substantially EquivalentGuangzhou Ajax Medical Equipment Co., Ltd.
FDA 510(k) clearance K252110 for Dental X-RAY Unit (AJX200), Substantially Equivalent on 2026-03-12. Applicant: Guangzhou Ajax Medical Equipment Co., Ltd.. Device class: 2.
Summary
Guangzhou Ajax Medical Equipment's Dental X-RAY Unit (AJX200) is filed under EHD, extraoral x-ray units with timer. The name is generic apart from the AJX200 designation.
Class II, 21 CFR 872.1800. The Radiology review panel handled it as a Traditional 510(k), though the record lists Dental as the classification panel.
Guangzhou Ajax Medical Equipment filed from Guangzhou, China. Review took 248 calendar days (July 7, 2025 to March 12, 2026).
Clearance details
- Applicant
- Guangzhou Ajax Medical Equipment Co., Ltd.
- Product code
- Product code EHD
- Device class
- Class 2
- Regulation
- 21 CFR 872.1800
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
Recent devices under product code EHD
view allMore clearances from Guangzhou Ajax Medical Equipment Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.