Muse Cardiovascular Information System

• • Ongoing Z-1938-2025 FDA Class II ·initiated 25 Apr 2025

  The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data.

510(k) Number

K992637 ↗

FDA Product Code

DSI

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Case 8000 Exercise Testing System

  Not classified

  FDA 510(k) K991014 Active Cleared 20 Oct 1999

• Solar 7/8000

  Class II

  FDA 510(k) K993757 Active Cleared 23 Mar 2000

• Bis/EEG Module

  Class II

  FDA 510(k) K012466 Active Cleared 1 Oct 2001

• Solar 8000M System Open recall

  Class II

  FDA 510(k) K012467 Active Cleared 11 Feb 2002

• Dash 3000 Patient Monitor Open recall

  Class II

  FDA 510(k) K992929 Active Cleared 26 Nov 1999

• Dash 3000/4000 Patient Monitor Open recall

  Class II

  FDA 510(k) K001359 Active Cleared 18 Jul 2000

See all devices from General Electric Medical Systems Information Techn →