510(k) · Cleared
ClearedClearCalc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radformation, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Apr 9, 2020 as substantially equivalent to K090531 (Lifeline Software, Inc., 2009) after a 104-day review. Its family tree reaches back 5 generations to 1992. 2 later devices descend from it.
- Decided
- Apr 9, 2020
- Review
- 104 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K914698 (1992). 8 ancestors in all, the oldest K911612 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 4 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 3 generations backK012227 Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc. · 2001
- 2 generations backK061152 Mucheck V7.0Oncology Data Systems, Inc. · 2006
- 1 generation backK090531 Radcalc Software, Version 6.0Lifeline Software, Inc. · 2009
- This deviceK193640 ClearCalcRadformation, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK220582 ClearCalc Model RADCA V2Radformation, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK252863 ClearCalc Model RADCA V2.6Radformation, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −4 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −3 | K012227 | Mucheck - Monitor Unit Validation Program, Model V4.1 | Oncology Data Systems, Inc. | 2001 | — |
| −2 | K061152 | Mucheck V7.0 | Oncology Data Systems, Inc. | 2006 | — |
| −1 | K090531 | Radcalc Software, Version 6.0 | Lifeline Software, Inc. | 2009 | — |
| 0 (this device) | K193640 | ClearCalc | Radformation, Inc. | 2020 | — |
| +1 | K220582 | ClearCalc Model RADCA V2 | Radformation, Inc. | 2022 | — |
| +2 | K252863 | ClearCalc Model RADCA V2.6 | Radformation, Inc. | 2025 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K090531 | Radcalc Software, Version 6.0Summary page 5…ber: 892.5050 Product Code: MUJ Classification Panel: Radiology 5.3. Predicate Device Information RadCalc: 510(k) Number K090531; Regulation number 892.5050; Product code: MUJ Radformation, Inc. 510(k) Submission… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220582 | ClearCalc Model RADCA V2 | 2022 | 1 |
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 28 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K220582 (Radformation, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K090531.
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. 2020, 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?
ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193640: ClearCalc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193640
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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