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FDA 510(k)

Portable Dental X-ray System Model PDX nova

K-Number: K260367 · 2026-05-27

ApplicantPDX Co., Ltd.
Decision Date2026-05-27
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Portable Dental X-ray System Model PDX nova is the device name listed in this FDA 510(k) record. The listed applicant is PDX Co., Ltd.. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K260367. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portable Dental X-ray System Model PDX nova?

Portable Dental X-ray System Model PDX nova is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is PDX Co., Ltd.. The 510(k) number is K260367.

When did Portable Dental X-ray System Model PDX nova receive FDA 510(k) clearance?

Portable Dental X-ray System Model PDX nova received FDA 510(k) clearance on 2026-05-27, under 510(k) number K260367.

Who is the listed applicant for Portable Dental X-ray System Model PDX nova?

The FDA 510(k) record lists PDX Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Dental X-ray System Model PDX nova?

The FDA product code for Portable Dental X-ray System Model PDX nova is EHD.

Related Devices (Code: EHD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.K251438Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )Guilin Woodpecker Medical Instrument Co., Ltd.K242185Rextar ProRaypia Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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