IDX-60 INTRAORAL X-RAY

• K Number: K993958
• Device Name: IDX-60 INTRAORAL X-RAY
• Manufacturer: X-CEL X-RAY CORP.
• Date Cleared: 2000-02-14 ( 84 days)
• Product Code: MUH
• Regulation Number: 872.1800
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Not Found

Device Description

IDX-160 Extraoral Source Dental X-Ray

AI/ML Overview

The provided documents are FDA 510(k) clearance letters for the "IDX-160 Extraoral Source Dental X-Ray" and "In X-60 Extraoral Source Dental X-Ray". These documents primarily focus on the regulatory classification and substantial equivalence determination for the devices. They do not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information based on the given text. The documents do not describe a study that proves the device meets acceptance criteria.

Regulation Number and Section

§ 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.