# K030594: I-125 Rapid Strand, Model 7000

- Pathway: 510(k) (Special)
- Applicant: Amersham Health
- Decided: Apr 10, 2003 after 44 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 K010621 (2001). 5 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940632: I-125 Rapid Strand, Medi-Physics Inc. Dba Nycomed Amersham Imaging (1994) Summary page 1.
- K914281: I-125 Seeds, Code: 6711, Medi-Physics Inc. Dba Nycomed Amersham Imaging (1991) Summary page 1.
- K022269: Coated Vicryl* (Polyglactin 910) Suture, ETHICON, Inc. (2002)
- K013964: Modification to Accu-Space Plain Gut Absorbable Seeding Spacers, Cp Medical (2002)

## Most influential descendants
- K040339: Brachytherapy Strand Device (2004), 14 descendants of its own
- K043596: Theraload Custom Loaded Needles, Models 200 and 125.S06 (2005), 9 descendants of its own
- K062384: Cesium-131 Strand, Strand Preload, Preload, S-Cartridge (2006), 7 descendants of its own
- K092136: Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5 (2009), 4 descendants of its own
- K180515: GammaTile (2018), 3 descendants of its own

## Indications for use
RAPID Strand TM is indicated for permanent interstitial implantation of selected localized tumors which are low to moderate radiosensitivity. They may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor. RAPID StrandTM may be 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/K030594
Methodology: https://510kreport.com/methodology