510(k) · Cleared
ClearedDiamond Setup 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K&S Assoc., Inc. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Jan 9, 2004 after a 115-day review. The FDA summary names no predicate by number. 24 later devices descend from it.
- Decided
- Jan 9, 2004
- Review
- 115 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 1 citing it directly.
- This deviceK032886 Diamond Setup 2000K&S Assoc., Inc. · 2004
- Descendant · cites it directly · 23 of its ownK140660 MOBIUS3DMobius Medical Systems, LP · 2014 · Recalled
- Descendant · 2 generations on · 13 of its ownK153014 Mobius3DMobius Medical Systems, LP · 2016
- Descendant · 3 generations on · 5 of its ownK191761 Mobius3DVarian Medical Systems, Inc. · 2019
- Descendant · 4 generations on · 4 of its ownK192424 Mobius3DVarian Medical Systems, Inc. · 2019
- Descendant · 3 generations on · 4 of its ownK171350 Collision CheckRadformation, Inc. · 2017
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K140660MOBIUS3DMobius Medical Systems, LP · 2014 · cites it directly23descendants
- K153014Mobius3DMobius Medical Systems, LP · 2016 · 2 generations on13descendants
- K191761Mobius3DVarian Medical Systems, Inc. · 2019 · 3 generations on5descendants
- K192424Mobius3DVarian Medical Systems, Inc. · 2019 · 4 generations on4descendants
- K171350Collision CheckRadformation, Inc. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032886 | Diamond Setup 2000 | K&S Assoc., Inc. | 2004 | — |
| +1 | K140660 | MOBIUS3D | Mobius Medical Systems, LP | 2014 | 1 |
| +2 | K153014 | Mobius3D | Mobius Medical Systems, LP | 2016 | — |
| +3 | K191761 | Mobius3D | Varian Medical Systems, Inc. | 2019 | — |
| +4 | K192424 | Mobius3D | Varian Medical Systems, Inc. | 2019 | — |
| +3 | K171350 | Collision Check | Radformation, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140660 | MOBIUS3D | 2014 | 23 |
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?
- Of its descendants, K140660 (Mobius Medical Systems, LP, 2014) has gone furthest, with 23 descendants of its own.
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.
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?
The current standard of care (AAPM, ACMP, ACR, etc.) in radiation oncology requires that the calculation results of each computer generated treatment plan be checked by some independent method. In the case of IMRT there is an additional requirement to perform measurements with ion chambers, TLD, film or other appropriate devices to ensure the accurate setup and delivery of the prescribed dose to the target organ and the limitation of dose to nearby…
Read the full statement (196 words)
The current standard of care (AAPM, ACMP, ACR, etc.) in radiation oncology requires that the calculation results of each computer generated treatment plan be checked by some independent method. In the case of IMRT there is an additional requirement to perform measurements with ion chambers, TLD, film or other appropriate devices to ensure the accurate setup and delivery of the prescribed dose to the target organ and the limitation of dose to nearby sensitive organs. The medical physicist has the primary responsibility for these quality assurance checks and independent calculations. The intended purpose of the Diamond Edition of Setup 2000 Version 3.0 software is to provide an accurate and convenient method of independently checking, on a point dose basis, the treatment planning calculations of the primary radiation treatment-planning (RTP) computer. The primary RTP computer is capable of importing CT images of the patient, identifying target volumes, superimposing the treatment beams and optimizing the weighting and modulation of the beam to produce an acceptable radiation distribution within the patient. The Diamond Edition of Setup 2000 Version 3.0 calculates point doses under specified conditions communicated to the software through operator interaction (keyboard and mouse) or through file import.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032886 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032886: Diamond Setup 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032886
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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