# K922117: C-Trak Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Care Wise Medical Products Corp.
- Decided: Oct 14, 1992 after 162 days
- Product code: IZD (Probe, Uptake, Nuclear)
- Device class: 1
- Regulation: 21 CFR 892.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K971167: Neoprobe Model 1500 Portable Radioisotope Detector and Accessories (1997), 3 descendants of its own
- K013751: Handheld Gamma Finder (HGF) (2002), 1 descendant of its own
- K101887: Confident Surgery Suite 300, Model CSS300 (2011), 0 descendants of its own
- K982442: C-Trak Automatic Analyzer (Name Change From Oncoprobe II to C-Trak) (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K922117
Methodology: https://510kreport.com/methodology