510(k) · Cleared
ClearedPanther StereoSeed
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 Dec 11, 2015 as substantially equivalent to K103576 (Mim Software, Inc., 2011) and 1 other predicate after a 365-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Dec 11, 2015
- Review
- 365 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K954874 (1996). 54 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet.
- Root · 9 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 5 generations between
- 3 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 2 generations backK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- 1 generation backK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
- This deviceK143514 Panther StereoSeedProwess, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 8 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 7 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 6 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 5 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 4 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 3 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 2 generations backK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- 1 generation backK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
- This deviceK143514 Panther StereoSeedProwess, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −8 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −7 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −6 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −5 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −4 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −3 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −2 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| −1 | K103576 | Mim 5.2 (Brachy) | Mim Software, Inc. | 2011 | — |
| 0 (this device) | K143514 | Panther StereoSeed | Prowess, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K103576 | Mim 5.2 (Brachy)Summary page 4…n Therapy Treatment Planning System, Brachytherapy Product Code: MUJ Predicate Devices: MIM Software Inc’s MIM 5.2 (Brachy), K103576, Product code LLZ Varian Medical System’s VariSeed 7.0, K012017, product code MUJ 3.… | 2011 |
| * | K012017 | Variseed 7.0Summary page 4…Predicate Devices: MIM Software Inc’s MIM 5.2 (Brachy), K103576, Product code LLZ Varian Medical System’s VariSeed 7.0, K012017, product code MUJ 3. Device Description Panther StereoSeed is an optional software module that has been added to the existi… | 2001 |
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 19 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 54 ancestors have a recall of any class.
- 6 other devices also cite its predicate K103576.
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. 2015, 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 Panther StereoSeed module is intended to create a plan that is optimized for seed locations and needle directions, allowing needles to be inserted in any angle in order to avoid critical structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143514: Panther StereoSeed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143514
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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