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K Number
K012355
Device Name
IMAGE-X SYSTEM
Manufacturer
TG GROUP, INC.
Date Cleared
2001-08-09

(15 days)

Product Code
EHD
Regulation Number
872.1800
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This extraoral source x-ray system is intended for dental radiographic examinations and diagnosis of diseases of the teeth, jaw, and oral structures.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the "Image-x System (Dental x-ray system)" and an "Indication For Use" statement. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested.

Therefore, I cannot provide the requested information based on the input document.

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.