Diamond Mammographic X-Ray System

• • Terminated Z-0976-2007 FDA Unclassified (pre-2012) ·initiated 16 Nov 2005

  GE Healthcare has become aware of the absence of thread-locking compound associated with the C-arm fasteners of your Diamond mammographic x-ray system that may impact patient safety.

510(k) Number

K000976 ↗

FDA Product Code

IZH

Device Class

Class II

Regulation

21 CFR Part 892.1710

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Magnaview M.R.I. Versions 110FH & 110FM W/Cardiac

  Class II

  FDA 510(k) K896309 Active Cleared 12 Jan 1990

• Instrumentarium MEGA4 Ht

  Class II

  FDA 510(k) K924921 Active Cleared 17 May 1993

• Delta 32 and Delta 32 Tact

  Class II

  FDA 510(k) K002472 Active Cleared 29 Nov 2000

• Mega 4 Magnetic Resonance Imaging System

  Class II

  FDA 510(k) K902044 Active Cleared 23 Aug 1990

• Instrumentarium MEGA4

  Class II

  FDA 510(k) K915552 Active Cleared 27 Feb 1992

• Magnaview Mobile MRI Version 110 Fhm

  Class II

  FDA 510(k) K891543 Active Cleared 23 Jun 1989

See all devices from Instrumentarium Imaging, Inc. →

• What clinical setting is the Diamond Mammographic X-Ray System intended for, and how does it support breast imaging?

  The Diamond Mammographic X-Ray System is designed specifically for radiology departments and clinical settings where breast cancer screening and diagnostic imaging are performed. It provides high-resolution X-ray visualization of breast tissue, aiding in the detection and diagnosis of breast abnormalities such as calcifications and masses. This makes it ideal for environments focused on early detection and accurate assessment of breast health.

• Is the Diamond Mammographic X-Ray System reusable or single-use, and what are the storage requirements?

  The regulatory records for the Diamond Mammographic X-Ray System do not specify whether it is single-use or reusable. Since it is a traditional Class II device intended for use in radiology settings, it is likely designed for repeated use in clinical environments. However, the specific storage conditions (e.g., temperature, humidity) are not detailed in the available data, so users should consult the manufacturer’s instructions for proper handling and maintenance.

• What regulatory pathway was followed for FDA clearance of the Diamond Mammographic X-Ray System, and what does this mean for its use?

  The Diamond Mammographic X-Ray System received FDA clearance through a 510(k) submission, classified as a Traditional clearance under regulation 892.1710. It was determined to be Substantially Equivalent (SESE) to a predicate device, meaning it meets the same performance and safety standards as an existing approved system. This clearance confirms its compliance with FDA requirements for mammographic imaging systems, ensuring it can be legally used in radiology departments for breast cancer screening and diagnostics in the U.S.

• Does the Diamond Mammographic X-Ray System have any special safety considerations for its operating environment?

  The Diamond Mammographic X-Ray System is designed to operate within standard MRI safety guidelines for non-MRI environments, meaning it is not intended for use inside an MRI suite. However, since it is an X-ray system, standard radiation safety protocols (e.g., shielding, operator training) should be followed to protect patients and staff during operation. No additional sterility or environmental storage conditions are specified in the regulatory records.