# K971167: Neoprobe Model 1500 Portable Radioisotope Detector and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Neoprobe Corp.
- Decided: Jun 26, 1997 after 87 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: 2 generations back to K942580 (1995). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962319: Neoprobe 1000 Gen 1C Portable Radioisotope Detector & Accessories, Neoprobe Corp. (1996) Summary page 2.
- K922117: C-Trak Biopsy System, Care Wise Medical Products Corp. (1992) Summary page 2.

## Most influential descendants
- 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

## Indications for use
The Neoprobe Model 1500 Portable Radioisotope Detector is an electronic device intended to detect and quantify gamma 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. For proper use and limitations of the Neoprobe Model 1500 refer to the product labeling.

Source page: https://510kreport.com/device/K971167
Methodology: https://510kreport.com/methodology