# K001070: Radiomed Source

- Pathway: 510(k) (Traditional)
- Applicant: Radiomed Corp.
- Decided: Oct 24, 2000 after 204 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: 1 generation back to K874787 (1987). 2 ancestors in all.
26 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874787: Modified Palladium Seed Model 100, Theragenics Corp. (1987) Summary page 1.
- K940632: I-125 Rapid Strand, Medi-Physics Inc. Dba Nycomed Amersham Imaging (1994) Summary page 1.
- (no number) Ir-192 Wires from Amersham International: named in the summary without a submission number

## Most influential descendants
- K013660: Genetra (2001), 23 descendants of its own
- K022326: Radiomed Marker (2003), 21 descendants of its own
- K031206: Radiomed Soft Tissue Marker (2003), 20 descendants of its own
- K070305: Pre-Loaded Visicoil (2007), 11 descendants of its own
- K080726: Calypso 4D Localization System (2008), 9 descendants of its own

## Indications for use
The RadioMed™ Source with activities from 0.1 to 5.0mCi per centimeter is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized tumors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual disease after excision of primary or recurrent tumors. The Pd-103 sources may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumorsare commonly treated.

Source page: https://510kreport.com/device/K001070
Methodology: https://510kreport.com/methodology