510(k) · Cleared
ClearedRadiation Planning Assistant (RPA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
University of Texas, MD Anderson Cancer Center · MUJ System, Planning, Radiation Therapy Treatment
Cleared on May 17, 2023 as substantially equivalent to K181145 (Varian Medical Systems, Inc., 2018) after a 251-day review. Its family tree reaches back 15 generations to 2001. 2 later devices descend from it.
- Decided
- May 17, 2023
- Review
- 251 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K010975 (2001). 19 ancestors in all, the oldest K992762 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 11 generations between
- 3 generations backK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 2 generations backK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 1 generation backK181145 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2018 · Recalled
- This deviceK222728 Radiation Planning Assistant (RPA)University of Texas, MD Anderson Cancer Center · 2023
- Descendant · cites it directly · 1 of its ownK242822 ART-Plan+ (v.3.0.0)Therapanacea Sas · 2025
- Descendant · 2 generations on · 0 of its ownK253091 ART-Plan+ (v3.1.0)Therapanacea Sas · 2025
Show all 15 generations
- Root · 15 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 14 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 13 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 12 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 11 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 10 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 9 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 8 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- 7 generations backK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013
- 6 generations backK133247 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014
- 5 generations backK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
- 4 generations backK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
- 3 generations backK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 2 generations backK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 1 generation backK181145 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2018 · Recalled
- This deviceK222728 Radiation Planning Assistant (RPA)University of Texas, MD Anderson Cancer Center · 2023
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 |
|---|---|---|---|---|---|
| −15 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −14 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −13 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −12 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −11 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −10 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −9 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −8 | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | 5 |
| −7 | K131891 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2013 | — |
| −6 | K133247 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | — |
| −5 | K141283 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | 1 |
| −4 | K152393 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2015 | 1 |
| −3 | K170969 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
| −2 | K172163 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
| −1 | K181145 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2018 | 1 |
| 0 (this device) | K222728 | Radiation Planning Assistant (RPA) | University of Texas, MD Anderson Cancer Center | 2023 | — |
| +1 | K242822 | ART-Plan+ (v.3.0.0) | Therapanacea Sas | 2025 | — |
| +2 | K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (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 |
|---|---|---|---|
| * | K181145 | Eclipse Treatment Planning SystemSummary page 4…therapy system Regulatory Class: II Product Code: MUJ 3. PREDICATE DEVICE Eclipse Treatment Planning System v15.6 (K181145) 4. DEVICE DESCRIPTION Design Characteristics The Radiation Planning Assistant (RPA) is a web-based contouring and radioth… | 2018 |
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 |
|---|---|---|---|
| K242822 | ART-Plan+ (v.3.0.0) | 2025 | 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 22 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 11 of the 19 ancestors have a recall of any class.
- Of its descendants, K242822 (Therapanacea Sas, 2025) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K181145.
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. 2023, 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?
The Radiation Planning Assistant (RPA) is used to plan radiotherapy treatments for patients with cancers of the head and neck, cervix, breast, and metastases to the brain. The RPA is used to plan external beam irradiation with photon beams using CT images. The RPA is used to create contours and treatment plans that the user imports into their own Treatment Planning System (TPS) for review, editing, and re-calculation of the dose. Some functions of the…
Read the full statement (116 words)
The Radiation Planning Assistant (RPA) is used to plan radiotherapy treatments for patients with cancers of the head and neck, cervix, breast, and metastases to the brain. The RPA is used to plan external beam irradiation with photon beams using CT images. The RPA is used to create contours and treatment plans that the user imports into their own Treatment Planning System (TPS) for review, editing, and re-calculation of the dose.
Some functions of the RPA use Eclipse 15.6. The RPA is not intended to be used as a primary treatment planning system. All automatically generated contours and plans must be imported into the user's own treatment planning system for review, edit, and final dose calculation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222728: Radiation Planning Assistant (RPA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222728
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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