MAM-CH22S With Automatic Filter Selection Option

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K960381 ↗

FDA Product Code

IZH

Device Class

Class II

Regulation

21 CFR Part 892.1710

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Gyrex 2T Prestige Model No. 100-6321-0107 and Gyrex Privilege Model No. 100-6326-0102

  Class II

  FDA 510(k) K965044 Active Cleared 16 Jun 1997

• Head and Neck Coil for the Gyrex 2T-Dlx

  Class II

  FDA 510(k) K943320 Active Cleared 29 Nov 1994

• Dynex-44 Diagnostic Ultrasound Imaging

  Class II

  FDA 510(k) K812014 Active Cleared 16 Sep 1981

• Gyrex Privilege

  Class II

  FDA 510(k) K954039 Active Cleared 24 Nov 1995

• 2T Prestige(100-6321-0107)/Privilege(100-6326-0102)/Gyrex V-Ep(100-6327-0101)

  Class II

  FDA 510(k) K972592 Active Cleared 15 Sep 1997

• Ultrasound Equipment Model Sdl-100A

  Not classified

  FDA 510(k) K837084 Active Cleared 28 Apr 1983

See all devices from Elscint, Inc. →

• What is the MAM-CH22S mammography system with automatic filter selection?

  The MAM-CH22S is a mammographic X-ray system that includes an optional filter assembly with both molybdenum and rhodium filters, featuring an automatic mode of operation. It is a modification of the previously marketed mammography system K941353/S1.

• How is the MAM-CH22S system supplied and what are its regulatory approvals?

  The device is supplied by Elscint, Inc. and received FDA 510(k) clearance on April 29, 1996. It is classified as Class II - Special Controls under product code IZH, with the automatic filter selection option specifically for the MAM-CH22S mammography system.

• What are the key features of the automatic filter selection option in the MAM-CH22S system?

  The automatic filter selection option allows the system to automatically choose between molybdenum and rhodium filters based on imaging requirements. This feature enhances imaging capabilities by optimizing filter selection for different breast tissue densities and thicknesses without manual intervention.

• What is the classification and regulatory route of the MAM-CH22S system?

  The MAM-CH22S system is classified as Class II - Special Controls under product code IZH. It underwent the traditional 510(k) clearance process and was determined to be substantially equivalent to existing predicate devices, receiving clearance on April 29, 1996.