MXR-2000 MOBILE X-RAY UNIT

• K Number: K010304
• Device Name: MXR-2000 MOBILE X-RAY UNIT
• Manufacturer: IROM IMAGING, INC.
• Date Cleared: 2001-02-12 ( 11 days)
• Product Code: IZL
• Regulation Number: 892.1720
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: K012663

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

AI/ML Overview

Get notified when PDF is available

Summary

Loading...

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.