# K040766: Optisource, Model 1032P

- Pathway: 510(k) (Traditional)
- Applicant: International Brachytherapy S.A.
- Decided: Jul 22, 2004 after 119 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K131689: Mri Marker (2013), 1 descendant of its own
- K082159: Civastring PD-103 (2008), 1 descendant of its own
- K171487: Sirius MRI Marker NS (2017), 0 descendants of its own
- K140490: Civa Sheet PD-103 (2014), 0 descendants of its own

## Indications for use
OptiSource103 implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. OptiSource103 implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.

Source page: https://510kreport.com/device/K040766
Methodology: https://510kreport.com/methodology