510(k) · Cleared
ClearedProwess
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prowess, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Oct 16, 2003 as substantially equivalent to K021268 (Varian Medical Systems, Inc., 2002) and 3 other predicates after a 66-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Oct 16, 2003
- Review
- 66 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K862643 (1987). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK862643 Radiation Oncology Computer Sys Treatment PlanningPacific Physics, Inc. · 1987
- 2 generations backK970236 Theraplan Plus Version 1.2Theratronics, Inc. · 1997
- 1 generation backK980379 Prowess Pro-SimSsgi Prowess Systems · 1998
- This deviceK032456 ProwessProwess, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862643 | Radiation Oncology Computer Sys Treatment Planning | Pacific Physics, Inc. | 1987 | — |
| −2 | K970236 | Theraplan Plus Version 1.2 | Theratronics, Inc. | 1997 | — |
| −1 | K980379 | Prowess Pro-Sim | Ssgi Prowess Systems | 1998 | — |
| 0 (this device) | K032456 | Prowess | Prowess, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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? (4)
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 |
|---|---|---|---|
| * | K021268 | Eclipse, Helios Option | 2002 |
| * | K940663 | Peacock PlanSummary page 1…cate Devices: Varian Eclipse, Helios option KO21268 Nomos CORVUS Inverse Planning System K940663 ADAC P31MRT IMRT option KO02237 8. Device Description PROWESS PANTHER is an inverse p… | 1996 |
| * | K002237 | P3IMRT TMSummary page 2…achieves the treatment objectives. A proven and most widely used optimization algorithm, simulated annealing, was used. As with P31MRTTMsystem by ADAC (K002237), IMRT uses the convolution superposition algorithm as the final dose calculation engine. 3) DICOM Transfer --- T… | 2001 |
| * | K980379 | Prowess Pro-SimSummary page 1…escription PROWESS PANTHER is an inverse planning option to the Prowess radiation therapy planning software for supporting intensity-modulated radiation therapy (IMRT) (K980379). The Prowess 3D system is composed of a Workstation with an Intel Pentiurn* processors (or later versions) running Windows 2000… | 1998 |
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 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 15 ancestors has a recall.
- 1 other device also cites its predicate K021268.
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?
Prowess 3D Radiation Therapy Treatment Planning System, including the IMRT option Panther, is used to plan photon and electron radiation therapy treatments using linear accelerators and Cobalt-60 beams. The optional software module with the trade name Panther provides treatment planning for intensity-modulated radiation therapy (IMRT) treatments using external photon beams.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032456: Prowess.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032456
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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