510(k) · Cleared
Recalled · Class II · 2014Focal Sim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Computerized Medical Systems, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Dec 5, 2001 as substantially equivalent to K923851 (Philips Medical Systems (Cleveland), Inc., 1992) and 2 other predicates after a 78-day review. Its family tree reaches back 4 generations to 1992. 47 later devices descend from it. It has been recalled 10 times.
- Decided
- Dec 5, 2001
- Review
- 78 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 10
- Predicates
- 3
Its longest line of descent runs back 4 generations to K914698 (1992). 14 ancestors in all, the oldest K894706 (1989). 47 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 3 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 2 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 1 generation backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- This deviceK013112 Focal SimComputerized Medical Systems, Inc. · 2001
- Descendant · cites it directly · 32 of its ownK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
- Descendant · 2 generations on · 19 of its ownK061097 Coherence Dosimetrist, Model 2.2Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 18 of its ownK101119 Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 16 of its ownK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- Descendant · cites it directly · 13 of its ownK071938 Monaco RTP SystemComputerized Medical Systems, Inc. · 2007 · Recalled
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K022036Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002 · cites it directly32descendants
- K061097Coherence Dosimetrist, Model 2.2Siemens Medical Solutions USA, Inc. · 2006 · 2 generations on19descendants
- K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc. · 2010 · 3 generations on18descendants
- K031764Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · 2 generations on16descendants
- K071938Monaco RTP SystemComputerized Medical Systems, Inc. · 2007 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −3 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −2 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −1 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| 0 (this device) | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | — |
| +1 | K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +2 | K061097 | Coherence Dosimetrist, Model 2.2 | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| +3 | K101119 | Syngo Dosimetrist Workspace V2.7 Model: 1056864 | Siemens Medical Solutions USA, Inc. | 2010 | 1 |
| +2 | K031764 | Oncor Avant-Garde with Coherence Workspaces | Siemens Medical Solutions USA, Inc. | 2003 | 17 |
| +1 | K071938 | Monaco RTP System | Computerized Medical Systems, Inc. | 2007 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K923851 | Acqsim Simulator/LocalizerSummary page 1…Workstation Accessory to Radiation Treatment Planning System System, Simulation, Radiation Therapy per 21CFR892.5840 Picker International Acgsim Simulator/Localizer - K923851 GE Advantage Sim - K951830 ADAC Advantage Sim - K993923 Device Description: (See Section 7 of this submittal for a more detail… | 1992 |
| * | K951830 | Advantage SimSummary page 1…diation Treatment Planning System System, Simulation, Radiation Therapy per 21CFR892.5840 Picker International Acgsim Simulator/Localizer - K923851 GE Advantage Sim - K951830 ADAC Advantage Sim - K993923 Device Description: (See Section 7 of this submittal for a more detailed Device Description). The… | 1995 |
| * | K993923 | Adac PINNACLE3TM Radiation Therapy Planning SystemSummary page 1…tem System, Simulation, Radiation Therapy per 21CFR892.5840 Picker International Acgsim Simulator/Localizer - K923851 GE Advantage Sim - K951830 ADAC Advantage Sim - K993923 Device Description: (See Section 7 of this submittal for a more detailed Device Description). The FOCAL Workstation was initiall… | 2000 |
What descends from it? (47)
See all 472 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2014 | Class II | Z-1244-2015 | Software design | Incorrect CT to ED when using the Monaco Image Statistics Tool. |
| Aug 18, 2014 | Class II | Z-2574-2014 | Software design | 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 plan. |
| Jun 21, 2012 | Class II | Z-2002-2012 | Software design | 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 | Software design | 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 to the R&V System, the gantry angles… |
| May 10, 2010 | Not classified | Z-2592-2011 | Software design | 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 user evaluated the plan based only on… |
| Jun 12, 2009 | Not classified | Z-2559-2011 | Software design | 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 reversed (left to right, anterior to… |
| Feb 6, 2009 | Not classified | Z-2599-2011 | Software design | 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 instead the leaves will then snap… |
| Jan 19, 2009 | Not classified | Z-2594-2011 | Software design | 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 not aligning the images sets if there… |
| Mar 31, 2008 | Not classified | Z-2572-2011 | Software design | 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 reflect blocked normalization. This is… |
| Nov 30, 2007 | Not classified | Z-2596-2011 | Software design | 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 not. XiO will recalculate dose when… |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K022036 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 32 descendants of its own.
- 6 other devices also cite its predicate K923851.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
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…
Read the full statement (122 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013112: Focal Sim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013112
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026