510(k) · Cleared
ClearedWimrt Module for Artp Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prodigm Group, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on May 20, 2005 as substantially equivalent to K940663 (Nomos Corp., 1996) and 2 other predicates after a 302-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- May 20, 2005
- Review
- 302 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K884261 (1989). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK884261 Prowess 2000Small Systems Group, Inc. · 1989
- 2 generations backK940663 Peacock PlanNomos Corp. · 1996
- 1 generation backK984532 Cadplan Helios Option 6.0Varian Medical Systems, Inc. · 1999
- This deviceK041971 Wimrt Module for Artp Planning SystemProdigm Group, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK090893 Tigrt TPSLinatech, LLC · 2009
Most influential descendants
Showing 1 of 1 · See all- K090893Tigrt TPSLinatech, LLC · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884261 | Prowess 2000 | Small Systems Group, Inc. | 1989 | — |
| −2 | K940663 | Peacock Plan | Nomos Corp. | 1996 | — |
| −1 | K984532 | Cadplan Helios Option 6.0 | Varian Medical Systems, Inc. | 1999 | — |
| 0 (this device) | K041971 | Wimrt Module for Artp Planning System | Prodigm Group, Inc. | 2005 | — |
| +1 | K090893 | Tigrt TPS | Linatech, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (3)
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 |
|---|---|---|---|
| * | K940663 | Peacock PlanSummary page 1…2. Name of Predicate Devices: (1) Manufacturer KNumber NOMOS Corvus Inverse Planning System K940663 Varian Helios Inverse Planning Module K984532 ADAC Laboratories P3IMRT Module K00… | 1996 |
| * | K984532 | Cadplan Helios Option 6.0Summary page 1…KNumber NOMOS Corvus Inverse Planning System K940663 Varian Helios Inverse Planning Module K984532 ADAC Laboratories P3IMRT Module K002237 Any statement made in conjunction with… | 1999 |
| * | K002237 | P3IMRT TMSummary page 1…se Planning System K940663 Varian Helios Inverse Planning Module K984532 ADAC Laboratories P3IMRT Module K002237 Any statement made in conjunction with this submission regarding substantial equivalence to an… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090893 | Tigrt TPS | 2009 | 0 |
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 4 companies; a new generation was cleared every 5.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K090893 (Linatech, LLC, 2009) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K940663.
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.
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 TOPSLANE product ARTP with WMPRT is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ALRTP with WIMPRT is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.
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/K041971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041971: Wimrt Module for Artp Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041971
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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