Cirrus Gamma Camera

• • Terminated Z-0785-2014 FDA Class II ·initiated 4 Dec 2013 ·on shared 510(k) K913471

  The recalling firm determined that visual inspections of the fork joints behind the detector that are conducted during six month preventive maintenance (PM) may not detect small cracks or deficiencies in the fork weldment.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K913471 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Jetstream Workspace

  Class II

  FDA 510(k) K042880 Active Cleared 3 Nov 2004

• Adac Model Dps-3300M Digital Processing System

  Class II

  FDA 510(k) K844298 Active Cleared 1 Mar 1985

• DPS-33000 Nuclear Medicine Imaging Computer

  Class II

  FDA 510(k) K844784 Active Cleared 1 Feb 1985

• Ensphere Tempo Jetstream Workspace Cardiology Module

  Class II

  FDA 510(k) K040142 Active Cleared 6 Feb 2004

• Skylight Imaging System

  Class II

  FDA 510(k) K000908 Active Cleared 5 Apr 2000

• Adac Viewpoint (Additional Software)

  Class II

  FDA 510(k) K884349 Active Cleared 22 Dec 1988

See all devices from Adac Laboratories →

• What is the primary use of the Cirrus Gamma Camera?

  The Cirrus Gamma Camera is a computed emission tomography system specifically designed for nuclear medicine imaging applications within the field of radiology.

• Who is the manufacturer of this device?

  This device is manufactured by Adac Laboratories, based in Milpitas, California.

• What is the regulatory classification of the Cirrus Gamma Camera?

  The device is classified as a Class II medical device under regulation number 892.1200 and received FDA 510(k) clearance in 1991 under reference number K913471.