# K140849: Isoseed

- Pathway: 510(k) (Abbreviated)
- Applicant: Eckert & Ziegler Bebig GmbH
- Decided: Jul 2, 2014 after 90 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K801748 (1980). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002429: Select Seed I-125, Nucletron Corp. (2001) Summary page 1.
- K033781: Bebig Isoseed I-125, Bebig Isotopen-Und Medizintechnik GmbH (2003) Summary page 1.
- K914281: I-125 Seeds, Code: 6711, Medi-Physics Inc. Dba Nycomed Amersham Imaging (1991) Summary page 1.

## Indications for use
IsoSeed 125.Sl7plus with apparent activities from 0.189 to 1.045 mCi are indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor. Seeds in this apparent activity range may be used to treat superficial, intraabdominal, and intrathoracic tumors. Tumors of the head, neck, lung, pancreas, and prostate (early stages) are commonly treated. IsoSeed 125.Sl7plus with total apparent activities greater than 1.045 mCi are indicated for interstitial treatment of tumors which have the following characteristics: unresectable, localized, and moderate radiosensitivity. These seeds may be used for selected radiation applications as temporary implants. IsoSeed 125.Sl7plus are indicated to treat residual tumors concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy. In addition, recurrent tumors may be implanted with IsoSeed 125.Sl7plus.

Source page: https://510kreport.com/device/K140849
Methodology: https://510kreport.com/methodology