510(k) · Cleared
Recalled · Class II · 2012Advantage Sim MD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · KPQ System, Simulation, Radiation Therapy
Cleared on Sep 14, 2005 as substantially equivalent to K021780 (General Electric Medical Systems, 2002) and 3 other predicates after a 19-day review. Its family tree reaches back 6 generations to 1995. 21 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 14, 2005
- Review
- 19 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 6 generations to K945512 (1995). 15 ancestors in all, the oldest K871859 (1987). 21 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 5 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 4 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 3 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 2 generations backK022919 Smart Breath Respiratory Compensation OptionGE Medical Systems · 2002
- 1 generation backK032915 Advantage 4D OptionGe Medical Systems, LLC · 2003
- This deviceK052345 Advantage Sim MDGE Healthcare · 2005
- Descendant · cites it directly · 11 of its ownK061671 Syngo Trued, Model VC10ASiemens Medical Solutions · 2006
- Descendant · 2 generations on · 9 of its ownK071241 LMS-LiverMedian Technologies · 2007
- Descendant · cites it directly · 8 of its ownK132045 Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft · 2013
- Descendant · 3 generations on · 8 of its ownK121213 VitreaadvancedVital Images, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 7 of its ownK132944 Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K061671Syngo Trued, Model VC10ASiemens Medical Solutions · 2006 · cites it directly11descendants
- K071241LMS-LiverMedian Technologies · 2007 · 2 generations on9descendants
- K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft · 2013 · cites it directly8descendants
- K121213VitreaadvancedVital Images, Inc. · 2012 · 3 generations on8descendants
- K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −5 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −4 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −3 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −2 | K022919 | Smart Breath Respiratory Compensation Option | GE Medical Systems | 2002 | — |
| −1 | K032915 | Advantage 4D Option | Ge Medical Systems, LLC | 2003 | — |
| 0 (this device) | K052345 | Advantage Sim MD | GE Healthcare | 2005 | — |
| +1 | K061671 | Syngo Trued, Model VC10A | Siemens Medical Solutions | 2006 | — |
| +2 | K071241 | LMS-Liver | Median Technologies | 2007 | — |
| +1 | K132045 | Advantagesim MD with CT Atlas-Based Contouring and RE-Planning Options | Ge Hungary Kft | 2013 | — |
| +3 | K121213 | Vitreaadvanced | Vital Images, Inc. | 2012 | 1 |
| +2 | K132944 | Advantagesim MD MR Pelvic Organ at Risk Segmentation | Ge Hungary Kft | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K021780 | Advantage Sim 6.0Summary page 1…ted Devices Advantage Sim MD is substantially equivalent to the devices listed below: Model: Advantage Sim 6.0 Manufacturer: General Electric Medical Systems 510 (k): K021780 Model: Advantage 4D option Manufacturer: General Electric Medical Systems 510 (k): K032915 Model: Advantage Windows CT/PET Fus… | 2002 |
| * | K032915 | Advantage 4D OptionSummary page 1…: Advantage Sim 6.0 Manufacturer: General Electric Medical Systems 510 (k): K021780 Model: Advantage 4D option Manufacturer: General Electric Medical Systems 510 (k): K032915 Model: Advantage Windows CT/PET Fusion Manufacturer: General Electric Medical Systems 510 (k): K010336 1/4 GE H… | 2003 |
| * | K010336 | Advantage Windows CT/Pet FusionSummary page 1…D option Manufacturer: General Electric Medical Systems 510 (k): K032915 Model: Advantage Windows CT/PET Fusion Manufacturer: General Electric Medical Systems 510 (k): K010336 1/4 GE Healthcare Model: Volume Viewer Plus Manufacturer: General Electric Medical Systems 510 (k): K041521 .… | 2001 |
| * | K041521 | Volume Viewer PlusSummary page 2…: General Electric Medical Systems 510 (k): K010336 1/4 GE Healthcare Model: Volume Viewer Plus Manufacturer: General Electric Medical Systems 510 (k): K041521 . Device Description : AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam ra… | 2004 |
What descends from it? (21)
See all 212 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 |
|---|---|---|---|---|
| May 24, 2012 | Class II | Z-0754-2013 | Software design | It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if… |
| Nov 24, 2010 | Not classified | Z-1473-2011 | Software design | GE Healthcare has become aware that inconsistent DRR (Digitally Reconstructed Radiographic) visualization may occur when the blended DRR feature or the Isocenter Move mode feature is used in combination with specified other functions of… |
| Feb 2, 2009 | Not classified | Z-1718-2009 | Software design | It was reported by a customer site that when using Advantage Sim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 15 ancestors have a recall of any class.
- Of its descendants, K061671 (Siemens Medical Solutions, 2006) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K021780.
How does its category compare?
All KPQ devicesKPQ System, Simulation, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beamn radiotherapy treatment prior to dosimetry planning. 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 volumes may be assisted by additional CT, MR, PET or SPECT studies that have been co-registered with the…
Read the full statement (173 words)
AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beamn radiotherapy treatment prior to dosimetry planning. 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 volumes may be assisted by additional CT, MR, PET or SPECT studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user to define the target or treatment volume over a defined range of the respiratory cycle.
The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatment fields are displayed on transverse images, on reformatted sagittal, coronal or obligue images, on 3 D views created from the images, oron 2 beam eye’s view display with or without the display of defined structures with or without 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/K052345 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052345: Advantage Sim MD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052345
Report an extraction error
Are you the manufacturer?
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