# K142986: SagiNova

- Pathway: 510(k) (Traditional)
- Applicant: Eckert & Ziegler Bebig GmbH
- Decided: Apr 17, 2015 after 183 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K864210 (1986). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120993: Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX Brachytherapy Afterloader, Varian Medical Systems, Inc. (2012) Summary page 4.
- K953946: Microselectron-HDR Version 2, Nucletron-Oldelft Corp. (1996) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K142986
Methodology: https://510kreport.com/methodology