# K993552: Isoseed PD-103

- Pathway: 510(k) (Traditional)
- Applicant: Bebig Isotopentechnik GmbH
- Decided: Mar 31, 2000 after 163 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: 2 generations back to K801748 (1980). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982226: Uromed Brachytheraphy Iodine-125 Sources, Uromed Corp. (1999) Summary page 1.
- K874787: Modified Palladium Seed Model 100, Theragenics Corp. (1987) Summary page 1.

## Indications for use
The BEBIG Pd-103 Radionuclide Brachtherapy Sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intra-abdominal and intrathoracic tumors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.

Source page: https://510kreport.com/device/K993552
Methodology: https://510kreport.com/methodology