Merge PACS

• 2 recalls, same reason

  • Terminated Z-2062-2019 FDA Class II ·initiated 11 Jul 2019
  • Terminated Z-2063-2019 FDA Class II ·initiated 11 Jul 2019

  Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).

510(k) Number

K173475 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Merge Cardio

  Class II

  FDA 510(k) K192276 Active Cleared 20 Sep 2019

• Merge Universal Viewer (MUV)

  Class II

  CE/MDD FDA 510(k) K250301 Active Cleared 14 Apr 2025

• Merge Hemo

  Class II

  FDA 510(k) K152864 Active Cleared 7 Apr 2016

• IBM iConnect Access

  Class II

  FDA 510(k) K203104 Active Cleared 26 Jan 2021

• Merge Hemo, Model RCSV2 Open recall

  Class II

  FDA 510(k) K233326 Active Cleared 21 Jun 2024

• Merge PACS Open recall

  Class II

  FDA 510(k) K192455 Active Cleared 17 Oct 2019

See all devices from Merge Healthcare Incorporated →