# IZD: Probe, Uptake, Nuclear

- Device class: 1; regulation: 21 CFR 892.1320; FDA's rule: 510(k) exempt
- FDA decisions: 30
- Recalls: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1993: 2
- 1995: 1
- 1996: 1
- 1997: 2
- 1998: 1
- 1999: 1
- 2002: 1
- 2011: 1
- 2013: 1
- 2014: 1

## Most-cited predicates
- K971167: Neoprobe Model 1500 Portable Radioisotope Detector and Accessories (1997), cited by 3
- K922117: C-Trak Biopsy System (1992), cited by 2
- K942580: Neoprobe 1000 Portable Radioisotope Detector and Accessories (1995), cited by 1
- K962319: Neoprobe 1000 Gen 1C Portable Radioisotope Detector & Accessories (1996), cited by 1
- K896588: Oncoprobe II System (1990), cited by 1
- K961321: Gamma Guidance System (1997), cited by 1
- K013751: Handheld Gamma Finder (HGF) (2002), cited by 1

Source page: https://510kreport.com/product-code/IZD
Data by year (CSV): https://510kreport.com/product-code/IZD.csv