RIOScan RPS500
FDA 510(k)Class II (US FDA 510(k))
by Ray Co., Ltd
Identifiers
- 510(k) Number
- K160788 FDA 510(k)
- FDA Product Code
- MUH 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 RIOScan RPS500 is a computed radiography system designed for dental intraoral applications. It employs storage phosphor plates to capture and digitise X-ray images, replacing traditional film-based systems while maintaining diagnostic accuracy for intraoral dental imaging.
This device is intended for use in dental clinics and offices, where it is supplied as a reusable system with imaging plates that require exposure to X-rays during patient examinations. The RPS500 is classified as a Class II device under 21 CFR 872.1800 and received FDA 510(k) clearance through a Traditional 510(k) review, demonstrating substantial equivalence to predicate devices. No specific sterility or MRI safety information is provided in the regulatory data.
Frequently asked questions
How is the RIOScan RPS500 different from traditional film-based dental X-ray systems?
The RIOScan RPS500 replaces traditional film-based dental X-ray systems by using storage phosphor plates to capture and digitize intraoral X-ray images. Unlike film, which requires physical processing and development, this system provides immediate digital images, improving efficiency and diagnostic accuracy without compromising quality.
Is the RIOScan RPS500 system reusable, and how are the imaging plates handled?
Yes, the RIOScan RPS500 is supplied as a reusable system. The imaging plates themselves are designed to be exposed to X-rays during patient examinations and then processed to retrieve the digital images. The plates are not single-use but must be handled according to manufacturer guidelines to ensure proper reuse and image quality.
What regulatory pathway was followed for FDA clearance of the RIOScan RPS500?
The RIOScan RPS500 received FDA 510(k) clearance through a Traditional 510(k) review, demonstrating substantial equivalence to predicate devices. This means the manufacturer compared its device to an already cleared product and showed it had similar intended use, technology, and safety profile.
Are there any specific storage requirements for the RIOScan RPS500 system or its components?
The provided data does not specify storage conditions for the RIOScan RPS500 system or its imaging plates. However, since it is a reusable medical device, it should be stored in a clean, dry environment, protected from physical damage, and according to the manufacturer’s instructions to maintain performance and hygiene.
What types of dental imaging does the RIOScan RPS500 support, and is it limited to intraoral use?
The RIOScan RPS500 is explicitly designed for dental intraoral applications, meaning it is intended for capturing images inside the mouth, such as bitewing, periapical, and occlusal radiographs. While the data does not mention extraoral use, its classification and regulatory filing align with intraoral dental imaging systems.
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: RIOScan (RPS500) (K160788) — FDA 510 (k) | Innolitics, PDF 006_510(k) summary - Food and Drug Administration, PDF K160788 - RIOScan (RPS500), RIOScan (RPS500) — FDA 510 (k) K160788 | MedTracker, Rioscan (rps500) 510 (k) FDA Premarket Notification K160788 RAY CO., Ltd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160788 | Class II | Active |
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Manufacturer
- Manufacturer
- Ray Co., Ltd
- FDA Applicant
- Ray Co., Ltd.
Sources (1)
- FDA 510(k) K160788 24 fields · synced Sep 19, 2026