Senographe Dmr/Smr/Dm

• • Terminated Z-0283-04 FDA Unclassified (pre-2012) ·initiated 6 Feb 2004

  The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current.

510(k) Number

K913418 ↗

FDA Product Code

IZH

Device Class

Class II

Regulation

21 CFR Part 892.1710

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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