DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)

• K Number: K000976
• Device Name: DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
• Manufacturer: INSTRUMENTARIUM IMAGING, INC.
• Date Cleared: 2000-06-01 ( 66 days)
• Product Code: IZH
• Regulation Number: 892.1710
• 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

§ 892.1710 Mammographic x-ray system.

(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.