510(k) · Cleared
ClearedOncentra Gyn
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron Corporation · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Apr 16, 2008 as substantially equivalent to K031158 (Nucletron Corp., 2003) after a 15-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Apr 16, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K911612 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK911612 Nucletron Planning SystemNucletron-Oldelft Corp. · 1991
- 3 generations backK992303 Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0Nucletron Corp. · 2000
- 2 generations backK022739 Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model…Nucletron Corporation · 2002
- 1 generation backK031158 Swift 2.0, Model 132.001Nucletron Corp. · 2003
- This deviceK080929 Oncentra GynNucletron Corporation · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911612 | Nucletron Planning System | Nucletron-Oldelft Corp. | 1991 | — |
| −3 | K992303 | Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0 | Nucletron Corp. | 2000 | — |
| −2 | K022739 | Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model 132.002 | Nucletron Corporation | 2002 | — |
| −1 | K031158 | Swift 2.0, Model 132.001 | Nucletron Corp. | 2003 | — |
| 0 (this device) | K080929 | Oncentra Gyn | Nucletron Corporation | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (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 |
|---|---|---|---|
| * | K031158 | Swift 2.0, Model 132.001Summary page 1…below: Manufacturer Device 510(k) # Nucletron BV SWIFT 2.0 K031158 Description: Oncentra GYN is a "real time" treatment planning system for brachytherapy especially meant for the treatment of… | 2003 |
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 17 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K031158.
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. 2008, 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?
Oncentra GYN 1.0 is a software application intended for Brachytherapy Treatment Planning, for the treatment of cancer, ie. intercavitary, interstitial, intraluminal, involving radioactive sources.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080929: Oncentra Gyn.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080929
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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