G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY

• K Number: K960146
• Device Name: G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY
• Manufacturer: GE MEDICAL SYSTEMS
• Date Cleared: 1996-02-27 ( 42 days)
• Product Code: IZG
• Regulation Number: 892.1730
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 892.1730 Photofluorographic x-ray system.

(a)
Identification. A photofluorographic x-ray system is a device that includes a fluoroscopic x-ray unit and a camera intended to be used to produce, then photograph, a fluoroscopic image of the body. 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 discography kit intended for use with a photofluorographic 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.