510(k) · Cleared
ClearedAdvantagesim MD with CT Atlas-Based Contouring and RE-Planning Options
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Hungary Kft · KPQ System, Simulation, Radiation Therapy
Cleared on Sep 4, 2013 as substantially equivalent to K052345 (GE Healthcare, 2005) and 1 other predicate after a 64-day review. Its family tree reaches back 12 generations to 1991. 8 later devices descend from it.
- Decided
- Sep 4, 2013
- Review
- 64 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K913770 (1991). 113 ancestors in all, the oldest K871859 (1987). 8 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations between
- 3 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 2 generations backK102687 Mirada RTMirada Medical, Ltd. · 2010
- 1 generation backK130393 Mirada RTXMirada Medical, Ltd. · 2013
- This deviceK132045 Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft · 2013
- Descendant · cites it directly · 7 of its ownK132944 Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014
- Descendant · 2 generations on · 6 of its ownK151233 MonacoImpac Medical Systems, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 5 of its ownK183037 Monaco RTP SystemElekta, Inc. · 2018 · Recalled
- Descendant · 4 generations on · 4 of its ownK190178 Monaco RTP SystemElekta, Inc. · 2019 · Recalled
- Descendant · 5 generations on · 3 of its ownK202789 Monaco Rtp SystemElekta Solutions AB · 2021
Show all 12 generations
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 10 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 9 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 8 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 7 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 6 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 5 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 3 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 2 generations backK102687 Mirada RTMirada Medical, Ltd. · 2010
- 1 generation backK130393 Mirada RTXMirada Medical, Ltd. · 2013
- This deviceK132045 Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014 · cites it directly7descendants
- K151233MonacoImpac Medical Systems, Inc. · 2015 · 2 generations on6descendants
- K183037Monaco RTP SystemElekta, Inc. · 2018 · 3 generations on5descendants
- K190178Monaco RTP SystemElekta, Inc. · 2019 · 4 generations on4descendants
- K202789Monaco Rtp SystemElekta Solutions AB · 2021 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −11 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −10 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −9 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −8 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −7 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −6 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −5 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −3 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −2 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | — |
| −1 | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | — |
| 0 (this device) | K132045 | Advantagesim MD with CT Atlas-Based Contouring and RE-Planning Options | Ge Hungary Kft | 2013 | — |
| +1 | K132944 | Advantagesim MD MR Pelvic Organ at Risk Segmentation | Ge Hungary Kft | 2014 | — |
| +2 | K151233 | Monaco | Impac Medical Systems, Inc. | 2015 | 9 |
| +3 | K183037 | Monaco RTP System | Elekta, Inc. | 2018 | 6 |
| +4 | K190178 | Monaco RTP System | Elekta, Inc. | 2019 | 5 |
| +5 | K202789 | Monaco Rtp System | Elekta Solutions AB | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 7 | 0 |
| 2004 | 10 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 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 KPQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K052345 | Advantage Sim MDSummary page 1…and Re- planning Options Classification Names: 21CFR 892.5840, Radiology Product Code: KPQ Predicate Device(s): [K052345 - AdvontageSimM MID [K130393 - RTx (Mirado Medical Ltd. [IC) Device Description / AdvontogeSim TN MID… | 2005 |
| * | K130393 | Mirada RTXSummary page 1…ions Classification Names: 21CFR 892.5840, Radiology Product Code: KPQ Predicate Device(s): [K052345 - AdvontageSimM MID [K130393 - RTx (Mirado Medical Ltd. [IC) Device Description / AdvontogeSim TN MID is a CT/MR/PET oncology application used by… | 2013 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132944 | Advantagesim MD MR Pelvic Organ at Risk Segmentation | 2014 | 7 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 26 of the 113 ancestors have a recall of any class.
- Of its descendants, K132944 (Ge Hungary Kft, 2014) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K052345.
How does its category compare?
All KPQ devicesKPQ System, Simulation, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · KPQ
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KPQ
Too few KPQ 510(k)s in any year since 2007 to give a median.
Recalls per year · KPQ
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPQ
1in 2020
MAUDE reports naming product code KPQ, 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 | 1 | — | 6 | 17 |
| 2008 | 1 | — | 3 | 12 |
| 2009 | 1 | — | 1 | 7 |
| 2010 | 1 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 0 | — | 1 | 11 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 1 | — | 1 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
AdvantogeSini" MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dlosimetry planing. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volume may be assisted by additional CT. MIR or PET studies that have been co-registered ih the planning…
Read the full statement (170 words)
AdvantogeSini" MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dlosimetry planing. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volume may be assisted by additional CT. MIR or PET studies that have been co-registered ih the planning CT scan. Additionally ar & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined rangedo the respiratory cycle.
The geometric parameters of a proposed treatment field are seiectea to allow non-dosirnetric. interactive optimization of feic ccverage. Dlefined anatomical structures and geometric treatments fields ore displayed or. transv'erse images. on reformatted sagittal. coronad or oblique images. on 3D views created from the images. or on a beam eye's view display With or withoui the display of defined structures wirn or wtlnit the display of digitally reconstructed radiograph.
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/K132045 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132045: Advantagesim MD with CT Atlas-Based Contouring and RE-Planning Options.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132045
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026