510(k) · Cleared
ClearedProwess Pro-Sim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ssgi Prowess Systems · IYE Accelerator, Linear, Medical
Cleared on May 18, 1998 as substantially equivalent to K921991 (Nucletron-Oldelft Corp., 1992) and 3 other predicates after a 108-day review. Its family tree reaches back 2 generations to 1987. 3 later devices descend from it.
- Decided
- May 18, 1998
- Review
- 108 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K862643 (1987). 8 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK862643 Radiation Oncology Computer Sys Treatment PlanningPacific Physics, Inc. · 1987
- 1 generation backK970236 Theraplan Plus Version 1.2Theratronics, Inc. · 1997
- This deviceK980379 Prowess Pro-SimSsgi Prowess Systems · 1998
- Descendant · cites it directly · 0 of its ownK032456 ProwessProwess, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK992689 MU PlusRad Therapy Solutions, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK984196 Modification to Prowess Pro-SimSsgi Prowess Systems · 1998
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 |
|---|---|---|---|---|---|
| −2 | K862643 | Radiation Oncology Computer Sys Treatment Planning | Pacific Physics, Inc. | 1987 | — |
| −1 | K970236 | Theraplan Plus Version 1.2 | Theratronics, Inc. | 1997 | — |
| 0 (this device) | K980379 | Prowess Pro-Sim | Ssgi Prowess Systems | 1998 | — |
| +1 | K032456 | Prowess | Prowess, Inc. | 2003 | — |
| +1 | K992689 | MU Plus | Rad Therapy Solutions, Inc. | 2000 | — |
| +1 | K984196 | Modification to Prowess Pro-Sim | Ssgi Prowess Systems | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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 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? (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 |
|---|---|---|---|
| * | K921991 | Plato Radiation Therapy Planning SystemSummary page 1…tly in commercial distribution and previously determined to be substantially equivalent under section 510(k) including: Manufacturer 510(k) number Device Name Nucletron K921991 PLATO Theratronics International Ltd. K970236 Theraplan Plus Picker International, Inc. K923851 Picker Acqusim ROCS K862643 TPS 1… | 1992 |
| * | K970236 | Theraplan Plus Version 1.2Summary page 1…determined to be substantially equivalent under section 510(k) including: Manufacturer 510(k) number Device Name Nucletron K921991 PLATO Theratronics International Ltd. K970236 Theraplan Plus Picker International, Inc. K923851 Picker Acqusim ROCS K862643 TPS 1031 A description of the operating principles… | 1997 |
| * | K923851 | Acqsim Simulator/LocalizerSummary page 1…ction 510(k) including: Manufacturer 510(k) number Device Name Nucletron K921991 PLATO Theratronics International Ltd. K970236 Theraplan Plus Picker International, Inc. K923851 Picker Acqusim ROCS K862643 TPS 1031 A description of the operating principles and a detailed comparison of Prowess Pro- Sim to… | 1992 |
| * | K862643 | Radiation Oncology Computer Sys Treatment PlanningSummary page 1…ufacturer 510(k) number Device Name Nucletron K921991 PLATO Theratronics International Ltd. K970236 Theraplan Plus Picker International, Inc. K923851 Picker Acqusim ROCS K862643 TPS 1031 A description of the operating principles and a detailed comparison of Prowess Pro- Sim to other legally marketed devic… | 1987 |
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 11 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K032456 (Prowess, Inc., 2003) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K921991.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Prowess Pro-Sim is a modularly designed Radiation Treatment Planning Computer Program used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system is utilized to develop treatment plans for Brachytherapy and External Beam (photon or electron) therapy. Completed treatment plans can be simulated using Prowess Pro-Sim in 3D on the computer’s display prior to actual treatment. Prowess Pro-Sim acquires…
Read the full statement (163 words)
Prowess Pro-Sim is a modularly designed Radiation Treatment Planning Computer Program
used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation
treatment. The system is utilized to develop treatment plans for Brachytherapy and External
Beam (photon or electron) therapy. Completed treatment plans can be simulated using Prowess
Pro-Sim in 3D on the computer’s display prior to actual treatment.
Prowess Pro-Sim acquires CT and MR image data from a variety of DICOM compliant sources
via its server module called APEX. MRI and CT machine data is acquired in a standard format
from a variety of sources and stored in a database. Prowess Pro-Sim is used to contour and
simulate radiation treatment therapy. Depending on the type of therapy, contouring information
is passed from the Prowess Pro-Sim module to the Prowess 500 module for Brachytherapy
planning or the Prowess 3000 module for External Beam planning. Once planning is complete,
plans can be saved on the computer and printed using a variety of printers.
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/K980379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980379: Prowess Pro-Sim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980379
Report an extraction error
Are you the manufacturer?
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