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FDA 510(k)

Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)

K-Number: K201800 · 2020-12-28

ApplicantNanoray Co., Ltd.
Decision Date2020-12-28
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) is the device name listed in this FDA 510(k) record. The listed applicant is Nanoray Co., Ltd.. It received FDA 510(k) clearance on 2020-12-28 under 510(k) number K201800. 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 (NR-F350, CS 2400P, CS 2300P, R2 Port-X)?

Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) is a medical device that received FDA 510(k) clearance on 2020-12-28. The listed applicant is Nanoray Co., Ltd.. The 510(k) number is K201800.

When did Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) receive FDA 510(k) clearance?

Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) received FDA 510(k) clearance on 2020-12-28, under 510(k) number K201800.

Who is the listed applicant for Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)?

The FDA 510(k) record lists Nanoray 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 (NR-F350, CS 2400P, CS 2300P, R2 Port-X)?

The FDA product code for Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) 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.

K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.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.

Official Source

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

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