# K982442: C-Trak Automatic Analyzer (Name Change From Oncoprobe II to C-Trak)

- Pathway: 510(k) (Traditional)
- Applicant: Care Wise Medical Products Corp.
- Decided: Aug 25, 1998 after 42 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
Longest line of descent: 3 generations back to K942580 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971167: Neoprobe Model 1500 Portable Radioisotope Detector and Accessories, Neoprobe Corp. (1997) Summary page 2.
- K922117: C-Trak Biopsy System, Care Wise Medical Products Corp. (1992) Summary page 2.
- K896588: Oncoprobe II System, Care Wise Medical Products Corp. (1990) Summary page 2.

## Indications for use
The intended use of the device here in question, i.e. the Care Wise C-Trak Automatic Analyzer, remains unchanged from the intended use of prior predicate Care Wise and other portable radioisotope detectors. The Care Wise C-Trak Automatic Analyzer is designed-as are all similar devices- to detect and quantify the nuclear radiation. It is indicated for external and intraoperative detection of radioactivity in body tissues or organs, such as bowel, bone, lymphatics, and red blood cells, where radiopharmaceuticals are administered.

Source page: https://510kreport.com/device/K982442
Methodology: https://510kreport.com/methodology