# K983768: Modification to Gamma Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: Radiation Monitoring Devices, Inc.
- Decided: Jul 2, 1999 after 249 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 K961321 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961321: Gamma Guidance System, Radiation Monitoring Devices, Inc. (1997) Summary page 1.

## Indications for use
For the detection and quantification of gamma radiation from gamma-emitting isotopes in the body or tissues. Use for non-imaging procedures to measure the amount of radionuclide absorbed by a particular organ or body region in open-surgical, laparoscopic or thoracoscopic surgical procedures.

Source page: https://510kreport.com/device/K983768
Methodology: https://510kreport.com/methodology