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

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K201800

by Nanoray Co., Ltd

Identifiers

510(k) Number
K201800 FDA 510(k)
FDA Product Code
EHD FDA 510(k)
Models / Variants
NR-F350 FDA 510(k)EUDAMED
CS 2400P FDA 510(k)EUDAMED
CS 2300P FDA 510(k)EUDAMED
R2 Port-X FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.1800 FDA 510(k)
Regulation Number
872.1800 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an Extraoral X-Ray Unit with Timer, designed for dental imaging. It emits controlled X-ray beams to capture high-resolution images of teeth, jaws, and surrounding structures, aiding in the diagnosis of dental and maxillofacial conditions. The system is portable, enabling use in clinical, mobile, or remote settings where traditional fixed X-ray units are impractical.

The Portable Dental X-ray is supplied as a reusable medical device, intended for use in dental offices, clinics, or field settings. It operates under FDA 510K and MDR authorisations, classified as a Class II device under regulation 872.1800. Models include the NR-F350, CS 2400P, CS 2300P, and R2 Port-X, with no specified sterility requirements beyond standard pre-procedure disinfection protocols. Compatibility with MRI environments is not addressed in the data, and storage conditions are not detailed beyond typical medical device handling.

Frequently asked questions

What are the key differences between the NR-F350 and the CS 2400P/CS 2300P models in this portable dental X-ray system?

The data provided does not specify technical or functional differences between the NR-F350, CS 2400P, CS 2300P, and R2 Port-X models beyond their classification as portable extraoral X-ray units with timers. All models are designed for dental imaging of teeth, jaws, and surrounding structures, but exact specifications (e.g., resolution, weight, or portability features) are not detailed. The models are all reusable and intended for use in clinical, mobile, or remote settings.

How should I prepare this device for use in a clinical setting, particularly regarding sterility?

The Portable Dental X-ray is a reusable device, so sterility is not a built-in feature. Standard pre-procedure disinfection protocols must be followed to ensure hygiene. The device itself does not require sterilization beyond routine cleaning and disinfection as per established medical device protocols, as no specific sterility claims or packaging are mentioned in the data.

Are these models compatible with MRI environments, and if not, what precautions should I take?

The data does not address MRI compatibility for the Portable Dental X-ray models. If used near MRI equipment, standard safety protocols for X-ray devices should be followed, including ensuring the device is not exposed to strong magnetic fields. Always consult MRI safety guidelines and manufacturer instructions for specific precautions.

What regulatory pathways have been followed for this device, and how does that affect its use?

This device has been authorized under both FDA 510K and MDR (Medical Device Regulation) pathways, classified as a Class II device under regulation 872.1800. The FDA clearance indicates it is deemed substantially equivalent to a predicate device, while MDR compliance ensures it meets EU safety and performance standards. These pathways confirm the device’s regulatory standing but do not dictate clinical use—only that it meets specified safety and performance criteria.

What storage conditions should I follow for this portable dental X-ray system?

The data does not specify exact storage conditions beyond typical medical device handling. Generally, portable X-ray units should be stored in a clean, dry environment away from extreme temperatures, direct sunlight, or sources of physical damage. If the device is not in use for extended periods, follow manufacturer guidelines for maintenance to ensure optimal performance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nanoray Co., Ltd
FDA Applicant
Nanoray Co., Ltd.

Sources (2)

  • FDA 510(k) K201800 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026