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K Number
K082972
Device Name
KODAK 9500
Manufacturer
TROPHY
Date Cleared
2008-12-05

(60 days)

Product Code
MUH
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

Kodak 9500 Extra-oral x-ray imaging system is intended to produce three dimensional xray image of the dento-maxillo-facial area.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to complete the request. The document is a 510(k) clearance letter from the FDA, which confirms substantial equivalence to a predicate device. It does not include information about specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for the Kodak 9500 device.

§ 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.