510(k) · Cleared
ClearedRadcalc Software, Version 6.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifeline Software, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on May 27, 2009 as substantially equivalent to K061152 (Oncology Data Systems, Inc., 2006) and 1 other predicate after an 89-day review. Its family tree reaches back 4 generations to 1992. 17 later devices descend from it.
- Decided
- May 27, 2009
- Review
- 89 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K914698 (1992). 7 ancestors in all, the oldest K911612 (1991). 17 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 3 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 2 generations backK012227 Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc. · 2001
- 1 generation backK061152 Mucheck V7.0Oncology Data Systems, Inc. · 2006
- This deviceK090531 Radcalc Software, Version 6.0Lifeline Software, Inc. · 2009
- Descendant · cites it directly · 13 of its ownK153014 Mobius3DMobius Medical Systems, LP · 2016
- Descendant · 2 generations on · 5 of its ownK191761 Mobius3DVarian Medical Systems, Inc. · 2019
- Descendant · 3 generations on · 4 of its ownK192424 Mobius3DVarian Medical Systems, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK171350 Collision CheckRadformation, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK220583 ClearCheck Model RADCC V2Radformation, Inc. · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K153014Mobius3DMobius Medical Systems, LP · 2016 · cites it directly13descendants
- K191761Mobius3DVarian Medical Systems, Inc. · 2019 · 2 generations on5descendants
- K192424Mobius3DVarian Medical Systems, Inc. · 2019 · 3 generations on4descendants
- K171350Collision CheckRadformation, Inc. · 2017 · 2 generations on4descendants
- K220583ClearCheck Model RADCC V2Radformation, Inc. · 2022 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −3 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −2 | K012227 | Mucheck - Monitor Unit Validation Program, Model V4.1 | Oncology Data Systems, Inc. | 2001 | — |
| −1 | K061152 | Mucheck V7.0 | Oncology Data Systems, Inc. | 2006 | — |
| 0 (this device) | K090531 | Radcalc Software, Version 6.0 | Lifeline Software, Inc. | 2009 | — |
| +1 | K153014 | Mobius3D | Mobius Medical Systems, LP | 2016 | — |
| +2 | K191761 | Mobius3D | Varian Medical Systems, Inc. | 2019 | — |
| +3 | K192424 | Mobius3D | Varian Medical Systems, Inc. | 2019 | — |
| +2 | K171350 | Collision Check | Radformation, Inc. | 2017 | — |
| +3 | K220583 | ClearCheck Model RADCC V2 | Radformation, Inc. | 2022 | — |
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 |
|---|---|---|
| 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K061152 | Mucheck V7.0Summary page 1…Name: Medical Charged Particle Radiation Therapy System - Accessory Classification Regulation: 892.5050 5. Predicate Devices MuCheck - Monitor Unit/Dose Program K061152 RadCalc, Model V4.0 K010464 6. Device Description The RadCalc Software is a stand-alone program or… | 2006 |
| * | K010464 | Radcalc, Model V.4.0Summary page 1…e Radiation Therapy System - Accessory Classification Regulation: 892.5050 5. Predicate Devices MuCheck - Monitor Unit/Dose Program K061152 RadCalc, Model V4.0 K010464 6. Device Description The RadCalc Software is a stand-alone program or operating from a server… | 2001 |
What descends from it? (17)
See all 172 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 17 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K153014 (Mobius Medical Systems, LP, 2016) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K061152.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
RadCalc Software is a program utilized in a radiation therapy department for the determination of monitor units and/or the dose to various points of interest for external beam radiation therapy and/or brachytherapy treatments. For external beam treatments, RadCalc's monitor unit calculation can be used to validate the monitor units or dose previously determined by hand or by the primary radiation therapy planning system. RadCalc's function is to support…
Read the full statement (263 words)
RadCalc Software is a program utilized in a radiation therapy department for the determination of monitor units and/or the dose to various points of interest for external beam radiation therapy and/or brachytherapy treatments. For external beam treatments, RadCalc's monitor unit calculation can be used to validate the monitor units or dose previously determined by hand or by the primary radiation therapy planning system. RadCalc's function is to support the primary radiation therapy planning computer by validating its calculation as a means of quality assurance. RadCalc Software not only performs this secondary function but can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy treatment plan.
RadCalc Software imports treatment planning parameters from the primary treatment planning system or a verify and record system; parameters can also be entered manually. The dosimetric calculations are then performed for photon or electron external beam radiation plans or LDR, HDR, and Permanent Implant brachytherapy treatment plans. The brachytherapy treatment module is only used to validate the dose to points of interest and not for brachytherapy treatment planning.
RadCalc Software allows for the transfer of the treatment planning data from the primary radiation therapy planning computer or the Verify and Record system (system actually controlling the radiation beam) to RadCalc and then to the facility's Verify and Record system or radiation therapy planning computer. This electronic transfer of treatment planning data reduces the number of errors that could occur as a result of manually inputting the data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090531 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090531: Radcalc Software, Version 6.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090531
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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