# K903403: CT-Compatible Fletcher System Applicator

- Pathway: 510(k) (Traditional)
- Applicant: University of Michigan
- Decided: Oct 1, 1990 after 62 days
- Product code: IWJ (System, Applicator, Radionuclide, Manual)
- Device class: 1
- Regulation: 21 CFR 892.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
58 later devices descend from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K940663: Peacock Plan (1996), 57 descendants of its own
- K984532: Cadplan Helios Option 6.0 (1999), 27 descendants of its own
- K993766: Helax-TMS V 5.0 Radiation Therapy Treatment Planning System (1999), 24 descendants of its own
- K010682: Helax-TMS V 5.1 Radiation Therapy Treatment Planning System (2001), 23 descendants of its own
- K020971: DCM 2.0 (2002), 22 descendants of its own

Source page: https://510kreport.com/device/K903403
Methodology: https://510kreport.com/methodology