MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION

K960381 · Elscint, Inc. · IZH · Apr 29, 1996 · Radiology

Device Facts

• Record ID: K960381
• Device Name: MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
• Applicant: Elscint, Inc.
• Product Code: IZH · Radiology
• Decision Date: Apr 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1710
• Device Class: Class 2

Intended Use

The 510(k) premarket notification for the Automatic Filter Selection Option for the MAM-CH22S mammography system describes a modification of the legally marketed mammography system (K941353/S1) by the addition of the optional filter assembly (including molybdenum and rhodium filters) and its automatic mode of operation.

Device Story

Modification to MAM-CH22S mammography system; adds optional filter assembly containing molybdenum and rhodium filters; introduces automatic filter selection mode. System automatically selects rhodium filter for dense/thick breasts to optimize contrast and radiation dose. Used in clinical mammography settings by radiology staff. Output is optimized X-ray image. Benefits include improved image quality and dose management for challenging breast tissue.

Clinical Evidence

Bench testing only. Compliance with IEC 601-1 Medical Electrical Equipment safety standards. No clinical data provided.

Technological Characteristics

Mammography system with optional filter assembly (molybdenum and rhodium). Automatic filter selection mechanism. Complies with IEC 601-1 safety standards.

Indications for Use

Indicated for mammographic imaging of the breast. Automatic Filter Selection mode allows imaging of dense or thick breasts with improved contrast or reduced radiation dose via automatic rhodium filter selection.

Regulatory Classification

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.

Predicate Devices

• MAM-CH22S (K941353/S1)

Submission Summary (Full Text)

{0}

K960381

APR 29 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

The 510(k) premarket notification for the Automatic Filter Selection Option for the MAM-CH22S mammography system describes a modification of the legally marketed mammography system (K941353/S1) by the addition of the optional filter assembly (including molybdenum and rhodium filters) and its automatic mode of operation.

With regards to effectiveness, the intended use and the indications of use of the MAM-CH22S with the Automatic Filter Selection Option are identical to those of the MAM-CH22S. With the Automatic Filter Selection mode, dense or thick breasts can be imaged with improved contrast and/or less radiation dose when the mammography system automatically selects the rhodium filter.

With regards to safety, the MAM-CH22S mammography system with the Automatic Filter Selection Option was designed to comply with International Standard IEC (International Electrotechnical Commission) 601-1, Medical Electrical Equipment, Part 1: General Requirements For Safety. The modification was analyzed and preventive measures were taken.

Based on this analysis, to the best of our judgment, the addition of the Automatic Filter Selection Option modification to the MAM-CH22S mammography system, does not add a significant risk that can cause a safety hazard.

Based on the above, it is Elscint's opinion that the MAM-CH22S mammography system with the Automatic Filter Selection Option, is substantially equivalent in safety and effectiveness to the legally marketed device, MAM-CH22S.