510(k) · Cleared
ClearedSagiNova
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eckert & Ziegler Bebig GmbH · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Apr 17, 2015 as substantially equivalent to K120993 (Varian Medical Systems, Inc., 2012) and 1 other predicate after a 183-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Apr 17, 2015
- Review
- 183 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K864210 (1986). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 4 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 3 generations backK041933 Microselectron PDRNucletron Corp. · 2004
- 2 generations backK061354 Microselectron V3, Model 106.990Nucletron Corporation · 2006
- 1 generation backK120993 Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX…Varian Medical Systems, Inc. · 2012
- This deviceK142986 SagiNovaEckert & Ziegler Bebig GmbH · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −4 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −3 | K041933 | Microselectron PDR | Nucletron Corp. | 2004 | — |
| −2 | K061354 | Microselectron V3, Model 106.990 | Nucletron Corporation | 2006 | — |
| −1 | K120993 | Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX Brachytherapy… | Varian Medical Systems, Inc. | 2012 | — |
| 0 (this device) | K142986 | SagiNova | Eckert & Ziegler Bebig GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 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 JAQ? 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 JAQ device
- #1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 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 |
|---|---|---|---|
| * | K120993 | Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX Brachytherapy AfterloaderSummary page 4…: JAQ) Our devices is based on the legally marketed devices cited in the table below: Manufacturer Device 510(k) # Varian Gammamed plus IX Brachytherapy Afterloader, K120993 Gammamed plus 3/24 IX Brachytherapy Afterloader Nucletron MicroSelectron HDR version 2 K953946 Reference Device… | 2012 |
| * | K953946 | Microselectron-HDR Version 2Summary page 4…urer Device 510(k) # Varian Gammamed plus IX Brachytherapy Afterloader, K120993 Gammamed plus 3/24 IX Brachytherapy Afterloader Nucletron MicroSelectron HDR version 2 K953946 Reference Device Scientific methodology was supported by the reference device cited in the table below Manufactur… | 1996 |
| † | K852842 | Selectron HDR Remote Afterloader | 1986 |
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 29 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K120993.
How does its category compare?
All JAQ devicesJAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JAQ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAQ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAQ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAQ
3in 2025
MAUDE reports naming product code JAQ, 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 | 11 | 48 | 0 | 13 |
| 2008 | 10 | 34 | 5 | 32 |
| 2009 | 10 | 27 | 1 | 35 |
| 2010 | 2 | — | 2 | 36 |
| 2011 | 2 | — | 13 | 42 |
| 2012 | 7 | 89 | 5 | 34 |
| 2013 | 6 | 100 | 1 | 43 |
| 2014 | 7 | 116 | 0 | 18 |
| 2015 | 11 | 183 | 0 | 7 |
| 2016 | 6 | 154 | 0 | 3 |
| 2017 | 7 | 229 | 0 | 5 |
| 2018 | 7 | 252 | 0 | 2 |
| 2019 | 2 | — | 1 | 8 |
| 2020 | 4 | 62 | 0 | 8 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 10 | 126 | 0 | 1 |
| 2025 | 6 | 91 | 0 | 3 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
SagiNova® is a family of Eckert & Ziegler BEBIG HDR afterloading systems that are intended to apply brachytherapy treatment to specific body sites (interstitial, intracavitary, intraluminal, and intra-operative or skin surface) with a remote controlled radioactive source. The systems are intended to be used by medical professionals trained in radiation oncology.
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/K142986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142986: SagiNova.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142986
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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