Portable Dental X-ray System Model PDX nova— 510(k) K260367
Substantially EquivalentPDX Co., Ltd.
FDA 510(k) clearance K260367 for Portable Dental X-ray System Model PDX nova, Substantially Equivalent on 2026-05-27. Applicant: PDX Co., Ltd.. Device class: 2.
Summary
PDX Co.'s Portable Dental X-ray System Model PDX nova is filed under EHD, extraoral x-ray units with timer.
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.
The record gives the location as Anyang-Si, Gyeonggi-Do, with country code CN. The decision came 112 calendar days after receipt (February 4 to May 27, 2026).
Clearance details
- Applicant
- PDX 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
- Anyang-Si, Gyeonggi-Do, CN
Recent devices under product code EHD
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