510(k) · Cleared
ClearedSciMoCa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radialogica, LLC · IYE Accelerator, Linear, Medical
Cleared on Apr 4, 2018 as substantially equivalent to K140660 (Mobius Medical Systems, LP, 2014) and 1 other predicate after a 29-day review. Its family tree reaches back 6 generations to 1992. 3 later devices descend from it.
- Decided
- Apr 4, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K914698 (1992). 15 ancestors in all, the oldest K874893 (1988). 3 later devices descend from it, 3 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 backK012227 Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc. · 2001
- 3 generations backK072374 CompassScanditronix Wellhofer GmbH · 2007 · Recalled
- 2 generations backK140660 MOBIUS3DMobius Medical Systems, LP · 2014 · Recalled
- 1 generation backK161946 DoseCHECKSun Nuclear Corporation · 2016
- This deviceK180595 SciMoCaRadialogica, LLC · 2018
- Descendant · cites it directly · 0 of its ownK223234 Delta4 InsightScandidos AB · 2024
- Descendant · cites it directly · 0 of its ownK231273 ArcherQA (V1.0)Wisdom Technologies., Inc. · 2024
- Descendant · cites it directly · 0 of its ownK213137 INTDoseCarina Medical, LLC · 2022
Most influential descendants
Showing 3 of 3 · See allView 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 | K012227 | Mucheck - Monitor Unit Validation Program, Model V4.1 | Oncology Data Systems, Inc. | 2001 | — |
| −3 | K072374 | Compass | Scanditronix Wellhofer GmbH | 2007 | 3 |
| −2 | K140660 | MOBIUS3D | Mobius Medical Systems, LP | 2014 | 1 |
| −1 | K161946 | DoseCHECK | Sun Nuclear Corporation | 2016 | — |
| 0 (this device) | K180595 | SciMoCa | Radialogica, LLC | 2018 | — |
| +1 | K223234 | Delta4 Insight | Scandidos AB | 2024 | — |
| +1 | K231273 | ArcherQA (V1.0) | Wisdom Technologies., Inc. | 2024 | — |
| +1 | K213137 | INTDose | Carina Medical, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K140660 | MOBIUS3DSummary page 5…CFR 892.5050 Product Code: IYE Class II ©Radialogica LLC 2018 All rights reserved 5-1 Predicate Devices • K140660 Mobius3D (Mobius Medical Systems, LP) • K161946 Model 1217028 DoseCHECK (Sun Nuclear Corporation) Device Description: SciMo… | 2014 |
| * | K161946 | DoseCHECKSummary page 5…gica LLC 2018 All rights reserved 5-1 Predicate Devices • K140660 Mobius3D (Mobius Medical Systems, LP) • K161946 Model 1217028 DoseCHECK (Sun Nuclear Corporation) Device Description: SciMoCa is a standalone software product that allows clini… | 2016 |
What descends from it? (3)
3 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 26 years and passes through 7 companies; a new generation was cleared every 6.0 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K223234 (Scandidos AB, 2024) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K140660.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
SciMoCa is a software product intended to provide quality assurance of a radiotherapy dose calculated by a treatment planning system by allowing a clinician to re-calculate the dose with an independent dose calculation algorithm and compare the two doses.
SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180595 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180595: SciMoCa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180595
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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