GX-C Cephalometer
FDA 510(k)Class II (US FDA 510(k))
by Gendex Corp.
Identifiers
- 510(k) Number
- K920189 FDA 510(k)
- FDA Product Code
- EAG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.1830 FDA 510(k)
- Regulation Number
- 872.1830 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A cephalometer is a device used for measuring the head, particularly in dental and orthodontic applications. The GX-C Cephalometer is a dental specialty device classified as a cephalometer under regulation number 872.1830.
It received FDA 510(k) clearance (K920189) on April 28, 1992, as substantially equivalent to a predicate device. The device is manufactured by Gendex Corp. and is intended for use in dental settings, with no claims made regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions in the provided data.
Frequently asked questions
What is the GX-C Cephalometer used for?
The GX-C Cephalometer is used for measuring the head, particularly in dental and orthodontic applications, to provide accurate measurements for treatment and diagnosis.
Is the GX-C Cephalometer sterile or reusable?
The provided data does not make any claims regarding the sterility or reusable status of the GX-C Cephalometer, so its status in this regard is unclear.
What kind of clearance did the GX-C Cephalometer receive from the FDA?
The GX-C Cephalometer received FDA 510(k) clearance as substantially equivalent to a predicate device, with clearance number K920189.
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: GX-C CEPHALOMETER (K920189) — FDA 510 (k) | Innolitics, GX-C CEPHALOMETER 510 (k) K920189 - FDA.report, Gendex Corp FDA Filings, GX CEPH (K842463) — FDA 510 (k) | Innolitics, Gendex Corporation - Henry Schein
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K920189 | Class II | Active |
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Manufacturer
- Manufacturer
- Gendex Corp.
Sources (1)
- FDA 510(k) K920189 24 fields · synced Sep 25, 2026