Portable Dental X-ray System Model PDX nova— 510(k) K260367

Substantially Equivalent

PDX 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..

Clearance details

Applicant: PDX Co., Ltd.
Product code: Code EHD
Advisory panel: Dental
Date received: 2026-02-04
Decision date: 2026-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anyang-Si, Gyeonggi-Do, CN

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