Processor, Radiographic-Film, Automatic, Dental
FDA 510(k)Class II (US FDA 510(k))
by Gendex Corp.
Identifiers
- 510(k) Number
- K945682 FDA 510(k)
- FDA Product Code
- EGY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1900 FDA 510(k)
- Regulation Number
- 892.1900 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Processor, Radiographic-Film, Automatic, Dental is a device used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. It is classified as a Class II medical device. The device is used in radiology and is designed to process radiographic film. It is an automatic processor, meaning it can continuously process film without manual intervention.
The device is supplied as a single unit and is intended for use in a medical setting. It is a reusable device, requiring maintenance and replacement parts for continued use. The device has been issued FDA 510(k) clearance, with the clearance number K945682. It is manufactured by Gendex Corp. and is classified under the product code EGY.
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: PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL (K945682) — FDA 510(k ..., Gendex Processor, Radiographic-Film, Automatic, Dental, PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL (K945682) — FDA 510(k ..., Parts for GENDEX: Dental Film & X-Ray Processors, Gendex Auto Xray Film Processor GXP sold out!!!
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K945682 | Class II | Active |
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Manufacturer
- Manufacturer
- Gendex Corp.
Sources (1)
- FDA 510(k) K945682 24 fields · synced Sep 24, 2026