# K940632: I-125 Rapid Strand

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Physics Inc. Dba Nycomed Amersham Imaging
- Decided: Sep 2, 1994 after 200 days
- Product code: IWI (Source, Isotope, Sealed, Gold, Titanium, Platinum)
- 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.
53 later devices descend from it; 7 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K001070: Radiomed Source (2000), 26 descendants of its own
- 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
- K030594: I-125 Rapid Strand, Model 7000 (2003), 17 descendants of its own

Source page: https://510kreport.com/device/K940632
Methodology: https://510kreport.com/methodology