CDR - PAN MODEL 4700

• K Number: K982661
• Device Name: CDR - PAN MODEL 4700
• Manufacturer: SCHICK TECHNOLOGIES, INC.
• Date Cleared: 1998-12-11 ( 134 days)
• Product Code: MQB , MUH
• Regulation Number: 892.1680
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

The CDR-PAN Panoramic Dental Digital Imager is indicated for use in acquiring radiographic images at the dento-maxillofacial region. It is intended to replace radiographic film/screen systems in panoramic dental diagnostic procedures.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the CDR-PAN Model 4700, an extraoral source x-ray system. The document does not contain information on acceptance criteria or a study proving the device meets acceptance criteria. The information provided is insufficient to answer the request.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.