510(k) · Cleared
ClearedMucheck V7.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oncology Data Systems, Inc. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on May 10, 2006 as substantially equivalent to K983343 (Nucletron Corp., 1999) and 2 other predicates after a 14-day review. Its family tree reaches back 3 generations to 1992. 21 later devices descend from it.
- Decided
- May 10, 2006
- Review
- 14 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K914698 (1992). 6 ancestors in all, the oldest K911612 (1991). 21 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 2 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 1 generation backK012227 Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc. · 2001
- This deviceK061152 Mucheck V7.0Oncology Data Systems, Inc. · 2006
- Descendant · cites it directly · 17 of its ownK090531 Radcalc Software, Version 6.0Lifeline Software, Inc. · 2009
- 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 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K090531Radcalc Software, Version 6.0Lifeline Software, Inc. · 2009 · cites it directly17descendants
- 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 |
|---|---|---|---|---|---|
| −3 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −2 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −1 | K012227 | Mucheck - Monitor Unit Validation Program, Model V4.1 | Oncology Data Systems, Inc. | 2001 | — |
| 0 (this device) | K061152 | Mucheck V7.0 | Oncology Data Systems, Inc. | 2006 | — |
| +1 | K090531 | Radcalc Software, Version 6.0 | Lifeline Software, Inc. | 2009 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 4 | 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? (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 |
|---|---|---|---|
| * | K983343 | Plato Brachytheraphy, Model V. 14.0Summary page 1…ed under section 514 Substantial Equivalence: Device Name 510(k)# Plato Brachytherapy (BPS v14.0) K983343 MuCheck - Monitor Unit Validation Program K980904 MuCheck - Monitor Unit/Dose Validation Program K012227… | 1999 |
| * | K980904 | Mucheck Monitor Unit Validation ProgramSummary page 1…510(k)# Plato Brachytherapy (BPS v14.0) K983343 MuCheck - Monitor Unit Validation Program K980904 MuCheck - Monitor Unit/Dose Validation Program K012227 Description: The BrachyCheck Dose Validation module is an opti… | 1998 |
| * | K012227 | Mucheck - Monitor Unit Validation Program, Model V4.1Summary page 1…py (BPS v14.0) K983343 MuCheck - Monitor Unit Validation Program K980904 MuCheck - Monitor Unit/Dose Validation Program K012227 Description: The BrachyCheck Dose Validation module is an optional software module that is part of the MuCheck software. MuChec… | 2001 |
What descends from it? (21)
See all 213 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 14 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K090531 (Lifeline Software, Inc., 2009) has gone furthest, with 17 descendants of its own.
- 5 other devices also cite its predicate K983343.
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?
In a radiation therapy department, a course of patient treatment is prescribed by a written directive from a radiation oncologist. Certain parameters from this directive are used by the medical dosimetrist and/or medical physicist along with x-rays or CT scans where applicable to plan a course of treatment. Typically a radiation treatment planning system is used to properly define the precise location and dose distribution for the radiation therapy. As…
Read the full statement (241 words)
In a radiation therapy department, a course of patient treatment is prescribed by a written directive from a radiation oncologist. Certain parameters from this directive are used by the medical dosimetrist and/or medical physicist along with x-rays or CT scans where applicable to plan a course of treatment. Typically a radiation treatment planning system is used to properly define the precise location and dose distribution for the radiation therapy. As part of the planning process monitor unit settings and dose to a volume or specific anatomical points will be generated.
The MuCheck - Monitor Unit/Dose validation Software verifies the monitor unit or dose calculated by the primary treatment planning system. MuCheck can also be used to calculate the monitor or dose for simple plans that do not require the use of the primary treatment planning system.
The intended use of the MuCheck software has been extended by the addition of an optional module called BrachyCheck. Brachycheck is used to verify brachytherapy procedures(implants using radioactive sources) performed by a brachytherapy treatment planning system. As part of the planning process, dwell positions will be generated and dose contributions from these dwell positions to specified anatomical points will be calculated.
The BrachyCheck module (device under review) verifies the dose calculated to the specified points by the primary treatment planning system. It serves as quality assurance as part of good treatment protocol to have a second means to verify the accuracy of the primary calculation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061152 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061152: Mucheck V7.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061152
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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