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Portable X-ray System Model Ray98(P)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K231449

by Ningbo Runyes Medical Instrument Co., Ltd.

Identifiers

510(k) Number
K231449 FDA 510(k)
FDA Product Code
EHD FDA 510(k)

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)

The Portable X-ray System Model Ray98(P) is a Class II extraoral dental X-ray unit with a built-in timer, designed for capturing high-quality radiographic images of dental structures. It operates as a portable device, enabling imaging in various clinical settings where fixed systems are impractical, such as patient homes, mobile clinics, or dental offices with limited space.

This system is supplied as a reusable medical device and is intended for use in dental practice settings. It requires appropriate training for operation and maintenance, adhering to standard radiation safety protocols. The device is authorized under FDA 510(k) clearance (K231449) and the EU Medical Device Regulation (MDR), with regulatory classification as a Class II device. Storage and handling follow standard guidelines for X-ray equipment to ensure functionality and safety.

Frequently asked questions

Is the Portable X-ray System Model Ray98(P) suitable for use outside traditional dental offices, like in patients' homes or mobile clinics?

Yes, the Ray98(P) is explicitly designed as a portable extraoral dental X-ray system, making it ideal for settings where fixed equipment isn’t practical. Its compact and mobile nature allows for use in patient homes, mobile clinics, or dental offices with limited space, as long as proper radiation safety protocols are followed and operators are trained.

How is the Portable X-ray System Model Ray98(P) supplied, and is it intended for single-use or reuse?

The Ray98(P) is supplied as a reusable medical device, not single-use. It requires appropriate training for operation and maintenance, including adherence to standard radiation safety protocols, to ensure safe and effective reuse across multiple patients.

What regulatory pathways has the Portable X-ray System Model Ray98(P) followed, and where is it authorized for use?

The Ray98(P) has undergone FDA 510(k) clearance (K231449) and is authorized under the EU Medical Device Regulation (MDR) as a Class II device. These pathways confirm its compliance with U.S. and EU standards for dental X-ray systems, ensuring it meets safety and performance requirements for clinical use in both regions.

Does the Portable X-ray System Model Ray98(P) come with built-in features to ensure consistent imaging quality, and how does it handle timing?

Yes, the Ray98(P) includes a built-in timer, which helps standardize exposure times for consistent radiographic imaging of dental structures. This feature is particularly useful in portable settings where precise control over imaging parameters is critical for diagnostic accuracy.

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. Sources consulted: PDF July 13, 2023 Ningbo Runyes Medical Instrument Co., Ltd., K231449 - Portable X-ray System Model Ray98(P) | FDA 510(k), Portable X-ray System Model Ray98 (P) (K231449) - Innolitics, Portable X-ray System Model Ray98(P) — FDA K231449, K231449 - Portable X-ray System Model Ray98(P) | FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ningbo Runyes Medical Instrument Co., Ltd.

Sources (2)

  • FDA 510(k) K231449 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026