510(k) · Cleared
ClearedAtlas-Based Autosegmentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Computerized Medical Systems, Inc. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Aug 7, 2008 as substantially equivalent to K053584 (Brainlab AG, 2006) and 2 other predicates after a 139-day review. Its family tree reaches back 6 generations to 1992. 29 later devices descend from it.
- Decided
- Aug 7, 2008
- Review
- 139 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K914698 (1992). 24 ancestors in all, the oldest K894706 (1989). 29 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 5 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 4 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 3 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 2 generations backK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
- 1 generation backK041577 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · Recalled
- This deviceK080799 Atlas-Based AutosegmentationComputerized Medical Systems, Inc. · 2008
- Descendant · cites it directly · 18 of its ownK101119 Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 9 of its ownK151380 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2015
- Descendant · cites it directly · 9 of its ownK111311 Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies) · 2011
- Descendant · 2 generations on · 8 of its ownK162370 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2016
- Descendant · 2 generations on · 8 of its ownK151887 syngo VSimSiemens Medical Solutions USA, Inc. · 2015
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc. · 2010 · cites it directly18descendants
- K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2015 · 2 generations on9descendants
- K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies) · 2011 · cites it directly9descendants
- K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2016 · 2 generations on8descendants
- K151887syngo VSimSiemens Medical Solutions USA, Inc. · 2015 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −5 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −4 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −3 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −2 | K032724 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2003 | 1 |
| −1 | K041577 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2004 | 7 |
| 0 (this device) | K080799 | Atlas-Based Autosegmentation | Computerized Medical Systems, Inc. | 2008 | — |
| +1 | K101119 | Syngo Dosimetrist Workspace V2.7 Model: 1056864 | Siemens Medical Solutions USA, Inc. | 2010 | 1 |
| +2 | K151380 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +1 | K111311 | Segmentation Assistant for Prostate-Auto Contouring | Omisa Inc. (Segasist Technologies) | 2011 | — |
| +2 | K162370 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2016 | — |
| +2 | K151887 | syngo VSim | Siemens Medical Solutions USA, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 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 LHN? 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 LHN device
- #1 K260597 Virtue QAscore 15.4 · 12 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 |
|---|---|---|---|
| * | K053584 | Iplan RT DoseSummary page 1…System, Simulation, Radiation Therapy per 21CFR892.5840 Substantial Equivalence: BrainLAB iPlan RT Dose (K053584) Pinnacle' (K041577); IKOEngelo (K061006); Level o… | 2006 |
| * | K041577 | PINNACLE3 Radiation Therapy Planning SystemSummary page 1…per 21CFR892.5840 Substantial Equivalence: BrainLAB iPlan RT Dose (K053584) Pinnacle' (K041577); IKOEngelo (K061006); Level of Concern & Rationale*: Major *Per FDA document "G… | 2004 |
| * | K061006 | IkoengeloSummary page 1…Equivalence: BrainLAB iPlan RT Dose (K053584) Pinnacle' (K041577); IKOEngelo (K061006); Level of Concern & Rationale*: Major *Per FDA document "Guidance for the Content of Premarket Submissions for Softwar… | 2006 |
What descends from it? (29)
See all 292 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)
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 16 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 6 of the 24 ancestors have a recall of any class.
- Of its descendants, K101119 (Siemens Medical Solutions USA, Inc., 2010) has gone furthest, with 18 descendants of its own.
- 1 other device also cites its predicate K053584.
How does its category compare?
All LHN devicesLHN System, Radiation Therapy, Charged-Particle, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LHN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHN
190in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LHN
11in 2025
MAUDE reports naming product code LHN, 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 | 2 | — | 2 | 0 |
| 2008 | 3 | 113 | 2 | 1 |
| 2009 | 5 | 69 | 0 | 5 |
| 2010 | 4 | 96 | 0 | 3 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 3 | 111 | 0 | 1 |
| 2013 | 3 | 70 | 0 | 1 |
| 2014 | 4 | 93 | 2 | 5 |
| 2015 | 3 | 53 | 1 | 2 |
| 2016 | 7 | 120 | 0 | 1 |
| 2017 | 4 | 173 | 5 | 7 |
| 2018 | 3 | 78 | 2 | 8 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 4 | 74 | 1 | 20 |
| 2021 | 0 | — | 1 | 24 |
| 2022 | 2 | — | 2 | 10 |
| 2023 | 2 | — | 1 | 7 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 3 | 190 | 0 | 11 |
| 2026 | 4 | 194 | 0 | — |
What is it indicated for?
Atlas-Based Autosegmentation is a standalone software application that produces estimates of anatomy boundary contours needed for the creation of a radiotherapy treatment plan.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080799 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080799: Atlas-Based Autosegmentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080799
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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