Monaco Rtp System

• • Terminated Z-2712-2016 FDA Class II ·initiated 18 Aug 2016

  In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner.

• • Terminated Z-2276-2013 FDA Class II ·initiated 2 Jul 2013

  Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.

• • Terminated Z-2277-2013 FDA Class II ·initiated 22 May 2013

  Patient needs to be positioned as indicated by the treatment plan.

• • Terminated Z-0841-2013 FDA Class II ·initiated 11 Feb 2013

  The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.

• • Terminated Z-2007-2012 FDA Class II ·initiated 21 Jun 2012

  Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.

• • Terminated Z-1365-2012 FDA Not yet classified ·initiated 5 Mar 2012

  An unnecessary dose refresh can occur in certain situations which causes inconsistencies in the Beam Doses and the Total Dose.

510(k) Number

K110730 ↗

FDA Product Code

MUJ

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Focus

  Class II

  FDA 510(k) K002147 Active Cleared 13 Oct 2000

• Enhanced Compensating Filter

  Class II

  FDA 510(k) K000137 Active Cleared 17 Apr 2000

• Focus Rtp System

  Class II

  FDA 510(k) K973936 Active Cleared 1 Jun 1998

• I-Beam

  Class II

  FDA 510(k) K032100 Active Cleared 2 Oct 2003

• Record and Verify Mevatron Adapter

  Class II

  FDA 510(k) K913674 Active Cleared 22 Nov 1991

• Focus Radiation Treatment Planning System

  Class II

  FDA 510(k) K020027 Active Cleared 8 Oct 2002

See all devices from Computerized Medical Systems, Inc. →