Sunipan Imaging System & Accessories
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K060149 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 Sunipan Imaging System & Accessories is a System, X-Ray, Extraoral Source, Digital, as classified under regulation number 872.1800 and product code MUH. It is designed for dental imaging applications, combining a base x-ray unit with an available aftermarket digital imaging sensor to create a filmless digital imaging system.
The device received FDA 510(k) clearance under K060149 on February 3, 2006, and is classified as a Class II medical device. It is manufactured by Suni Medical Imaging, Inc., and its authorization is based on substantial equivalence to a legally marketed predicate device. No claims are made regarding sterility, single-use or reusable status, MRI safety, specific sizes, storage conditions, or clinical indications beyond what is provided in the device classification and authorization data.
Frequently asked questions
What is the Sunipan Imaging System & Accessories used for?
The Sunipan Imaging System & Accessories is designed for dental imaging applications, functioning as a digital extraoral X-ray system that replaces film with a digital sensor to capture intraoral or extraoral images, based on its classification under regulation 872.1800 and product code MUH.
How is the Sunipan Imaging System & Accessories supplied or configured?
The system is supplied as a base X-ray unit that can be combined with an available aftermarket digital imaging sensor to create a filmless digital imaging system, as described in the device documentation, allowing for flexible configuration depending on the sensor used.
Is the Sunipan Imaging System & Accessories sterile or single-use?
No claims are made regarding sterility, single-use, or reusable status for the Sunipan Imaging System & Accessories, as explicitly stated in the device data, which does not provide any information on reprocessing, sterilization, or disposal requirements.
What regulatory pathway was used for the Sunipan Imaging System & Accessories?
The device received FDA 510(k) clearance under K060149 on February 3, 2006, based on substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device under product code MUH and regulation number 872.1800.
Are there specific sizes, models, or storage conditions for the Sunipan Imaging System & Accessories?
No specific sizes, models, or storage conditions are provided in the device data; the documentation does not include details on physical dimensions, storage requirements, or model variations beyond the system name and its classification as a digital extraoral X-ray system.
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: SUNIPAN IMAGING SYSTEM & ACCESSORIES (K060149) — FDA 510 (k) | Innolitics, Download Now: FDA 510 (k), K060149, SUNIPAN IMAGING SYSTEM ..., fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060149 | Class II | Active |
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Manufacturer
- Manufacturer
- Suni Medical Imaging, Inc.
Sources (1)
- FDA 510(k) K060149 24 fields · synced Sep 27, 2026