SIEMENS ORTHOPHOS DS/DS CEPH

• K Number: K972312
• Device Name: SIEMENS ORTHOPHOS DS/DS CEPH
• Manufacturer: SIEMENS AG
• Date Cleared: 1997-09-15 ( 87 days)
• Product Code: EHD
• Regulation Number: 872.1800
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

The Orthophos DS / DS Ceph is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Device Description

Not Found

AI/ML Overview

The provided documents are a 510(k) clearance letter and an Indications For Use statement for the Siemens Orthophos DS/DS Ceph Dental System. These documents confirm that the device has received regulatory clearance based on substantial equivalence to a predicate device. However, they do not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based solely on the provided text. The requested information is typical of a premarket approval (PMA) application or a more detailed 510(k) summary, which are not included in these documents.

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.