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K Number
K013271
Device Name
DXS DIGITAL X-RAY SYSTEM
Manufacturer
DOUGLAS C. YOON, DDS
Date Cleared
2001-12-13

(73 days)

Product Code
MUH
Regulation Number
872.1800
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
K033147
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

An extraoral source x-ray system which is a host PC powered device that produces digital radiographs and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw and supporting oral structures.

Device Description

An extraoral source x-ray system which is a host PC powered device that produces digital radiographs.

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification approval letter for a digital dental X-ray system. It does not contain any information about acceptance criteria, study details, performance metrics, ground truth, or sample sizes.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the given input.

§ 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.