# K013112: Focal Sim

- Pathway: 510(k) (Traditional)
- Applicant: Computerized Medical Systems, Inc.
- Decided: Dec 5, 2001 after 78 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K914698 (1992). 14 ancestors in all.
47 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923851: Acqsim Simulator/Localizer, Philips Medical Systems (Cleveland), Inc. (1992) Summary page 1.
- K951830: Advantage Sim, General Electric Co. (1995) Summary page 1.
- K993923: Adac PINNACLE3TM Radiation Therapy Planning System, Adac Laboratories (2000) Summary page 1.

## Most influential descendants
- K022036: Siemens Virtual Simulation (Vsim) (2002), 32 descendants of its own
- K061097: Coherence Dosimetrist, Model 2.2 (2006), 19 descendants of its own
- K101119: Syngo Dosimetrist Workspace V2.7 Model: 1056864 (2010), 18 descendants of its own
- K031764: Oncor Avant-Garde with Coherence Workspaces (2003), 16 descendants of its own
- K071938: Monaco RTP System (2007), 13 descendants of its own

## Recalls of this device
- Dec 19, 2014 · Class II · Z-1244-2015: Incorrect CT to ED when using the Monaco Image Statistics Tool.
- Aug 18, 2014 · Class II · Z-2574-2014: When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment pl
- Jun 21, 2012 · Class II · Z-2002-2012: Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
- Nov 9, 2010 · Not classified · Z-2562-2011: Focal: If a plan involving Dynamic MLC Delivery is sent from XiO to Focal and called up there in Plan Review, the angle of the gantry is set to zero for all beams. If this plan is then sent from Focal
- May 10, 2010 · Not classified · Z-2592-2011: Focal: for XiO plans calculated in relative dose mode, the Focal Plan Review application will display the DVH and maximum dose correctly. However, the isodose display is not scaled correctly. If the u
- Jun 12, 2009 · Not classified · Z-2559-2011: Focal Software: When a patient is defined as prone and the shifts are manually entered and the LOCK SHIFT box is checked the X coordinate (left/right) and the Z coordinate (anterior/posterior) are rev
- Feb 6, 2009 · Not classified · Z-2599-2011: Focal Software: if individual MLC leaf position edits are made, the original MLC aperture is retained. A subsequent aperture edit should not affect the MLC leaf positions however it was found that ins
- Jan 19, 2009 · Not classified · Z-2594-2011: Focal: the couch position can be moved between scans of the same CT study. When the images are imported into Focal, the software is not checking the DICOM Image Position (Patient) tag and therefore is
- Mar 31, 2008 · Not classified · Z-2572-2011: Focal: In absolute dose mode a beam with a port may be calculated with open normalization, with the result that the displayed dose reflects open normalization while the monitor units and QA plan refle
- Nov 30, 2007 · Not classified · Z-2596-2011: Focal: when a plan is sent to Focal from XiO and the structure properties are edited in Focal CT Sim activity, these changes result in changes to the MLC or field size for the plan when they should no

## Indications for use
The FOCAL workstation software is a computer software package intended to be used as an accessory to a radiation treatment planning system. FOCAL Sim is intended to permit CT simulation to be performed on the FOCAL workstation. The CT scan is read into the radiation treatment planning system and then sent to the FOCAL workstation. On FOCAL, the user is able to identify patient isocenters, place treatment beams and identify beam modifiers (blocks, wedges, etc.). This information is then passed back to the radiation treatment planning system for storage and documentation of the resultant treatment plan and calculation of patient dose based on this information. The resultant plan is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel.

Source page: https://510kreport.com/device/K013112
Methodology: https://510kreport.com/methodology