510(k) · Cleared
ClearedRaydose
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Raysearch Laboratories AB · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Oct 22, 2008 as substantially equivalent to K011246 (Mds Nordion, 2001) and 1 other predicate after a 77-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Oct 22, 2008
- Review
- 77 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K914698 (1992). 16 ancestors in all, the oldest K894706 (1989). No later device cites it as a predicate yet.
- 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 backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 3 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 2 generations backK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
- 1 generation backK041577 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · Recalled
- This deviceK082221 RaydoseRaysearch Laboratories AB · 2008
View 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 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −3 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −2 | K032724 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2003 | 1 |
| −1 | K041577 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2004 | 7 |
| 0 (this device) | K082221 | Raydose | Raysearch Laboratories AB | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K011246 | DCM 1.0 | 2001 |
| * | K041577 | PINNACLE3 Radiation Therapy Planning SystemSummary page 1…0 510(k) number KO1 1246 3 Pinnacle Radiation Therapy Planning System 510(k) number K041577 5.8 Device description RayDose is a software program, which offers dose calculation, either as a separate unit or as a… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 16 ancestors have a recall of any class.
- 2 other devices also cite its predicate K011246.
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. 2008, 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?
RayDose is software that computes dose (energy per volume deposited by ionizing radiation) three-dimensionally in a geometrical representation of a patient or a phantom, stemming from an external beam treatment unit in a radiation oncology clinic. The computed dose is intended to be used for clinical decisions on planned treatments or in quality assurance contexts. Based on various input data, RayDose is used to compute dose for linear accelerators with…
Read the full statement (114 words)
RayDose is software that computes dose (energy per volume deposited by ionizing radiation) three-dimensionally in a geometrical representation of a patient or a phantom, stemming from an external beam treatment unit in a radiation oncology clinic. The computed dose is intended to be used for clinical decisions on planned treatments or in quality assurance contexts.
Based on various input data, RayDose is used to compute dose for linear accelerators with X-ray energies from 6 to 18 MV, supporting the following collimation and modulation modalities:
o Symmetric and asymmetric rectangular fields
o Multileaf collimated fields
o Coplanar and non-coplanar fields
o Intensity modulated fields using Step-and-shoot technique
o Intensity modulated fields using Sliding Window technique
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082221: Raydose.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082221
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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