GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000

• • Terminated Z-2984-2018 FDA Class II ·initiated 22 Mar 2018

  The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

510(k) Number

K061129 ↗

FDA Product Code

IYN

Models / Variants

2188900

2375600

2404587

5150000

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Generator, High Volt, X-Ray, Diag. MPX80

  Class I

  FDA 510(k) K802548 Active Cleared 2 Dec 1980

• Senograph Ds, Senograph Essenstial

  Class II

  FDA 510(k) K103485 Active Cleared 6 Oct 2011

• Senographe Ds, Senographe Essential

  Class II

  FDA 510(k) K110798 Active Cleared 22 Dec 2011

• GE CT/T 8800 System

  Class II

  FDA 510(k) K780326 Active Cleared 14 Mar 1978

• CT Pace Catalog Number B7950A

  Class II

  FDA 510(k) K872526 Active Cleared 23 Sep 1987

• Series 620 Rectal Probe Cover

  Class II

  FDA 510(k) K864222 Active Cleared 4 Mar 1987

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