# K122764: Rapid Strand RX

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Physics, Inc.
- Decided: Dec 28, 2012 after 109 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 K010621 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063177: Rapid Strand RX, Oncura, Inc. (2006) Summary page 1.

## Indications for use
RAPID Strand Rx is 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. RAPID Strand Rx 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/K122764
Methodology: https://510kreport.com/methodology