Syngo.CT Cardiac Function

• • Terminated Z-1112-2019 FDA Class II ·initiated 21 Mar 2019

  There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.

510(k) Number

K110366 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Syngo.via

  Class II

  FDA 510(k) K123375 Active Cleared 20 Nov 2012

• Dental X-Ray Unit

  Class II

  FDA 510(k) K781286 Active Cleared 11 Sep 1978

• Siemens Polydoros 800

  Class I

  FDA 510(k) K820112 Active Cleared 24 Feb 1982

• Opti 110/12/50HSG

  Class I

  FDA 510(k) K810190 Active Cleared 2 Mar 1981

• Optiplanimat

  Class II

  FDA 510(k) K781531 Active Cleared 14 Sep 1978

• Somatom 2

  Class II

  FDA 510(k) K790975 Active Cleared 30 Jul 1979

See all devices from Siemens Corp. →