Cadstream Version 5

• • Terminated Z-0137-2017 FDA Class II ·initiated 30 Jan 2016

  The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up.

• • Terminated Z-2871-2016 FDA Class II ·initiated 1 Nov 2012

  An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.

• • Terminated Z-0118-2017 FDA Class II ·initiated 19 Oct 2011

  Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.

510(k) Number

K092954 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Cadstream Version 4.0

  Class II

  FDA 510(k) K043216 Active Cleared 6 Jan 2005

• Access Breast Coil 4/Sms

  Class II

  FDA 510(k) K060547 Active Cleared 29 Mar 2006

• Accent

  Class II

  FDA 510(k) K013574 Active Cleared 15 Jan 2002

• Confirma Breast MRI Interventional Components

  Class II

  FDA 510(k) K071534 Active Cleared 9 Jul 2007

• Cadstream, Version 5.0

  Class II

  FDA 510(k) K081556 Active Cleared 2 Feb 2009

• Cadstream

  Class II

  FDA 510(k) K031779 Active Cleared 6 Aug 2003

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