# K962319: Neoprobe 1000 Gen 1C Portable Radioisotope Detector & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Neoprobe Corp.
- Decided: Sep 13, 1996 after 88 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: 1 generation back to K942580 (1995). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942580: Neoprobe 1000 Portable Radioisotope Detector and Accessories, Neoprobe Corp. (1995) Summary page 2.

## 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

## Indications for use
The Neoprobe® Model 1000 GEN 1C Portable Radioisotope Detector is an electronic device intended to detect and quantify gamma radiation. The GEN 1C is indicated for external and intraoperative detection of radioactivity in body tissues or organs in medical procedures where gamma emitting isotopes are administered.

Source page: https://510kreport.com/device/K962319
Methodology: https://510kreport.com/methodology