Icon Computer System

• • Terminated Z-0727-03 FDA Unclassified (pre-2012) ·initiated 10 Feb 2003

  ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions.

510(k) Number

K914350 ↗

FDA Product Code

JWM

Device Class

Class II

Regulation

21 CFR Part 892.1310

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Multispect 3 Triple Detector Camera System

  Class II

  FDA 510(k) K911078 Active Cleared 17 Jun 1991

• Sienet Image Display Workstations, Image Acquisiti

  Class II

  FDA 510(k) K920319 Active Cleared 20 Oct 1992

• Carbon Fiber Pallet

  Class I

  FDA 510(k) K934766 Active Cleared 18 Feb 1994

• Ect (Emmission Computed Tomography) Carbon Fib Pal

  Class I

  FDA 510(k) K903767 Active Cleared 7 Sep 1990

• Gamma Camera

  Class I

  FDA 510(k) K810974 Active Cleared 13 May 1981

• Siemens Pacs/I-a

  Class II

  FDA 510(k) K880690 Active Cleared 31 Oct 1988

See all devices from Siemens Gammasonics, Inc. →