# K063691: Neutron Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Northern Illinois Univ. Outreach
- Decided: Jan 31, 2007 after 50 days
- Product code: IWL (System, Radiation Therapy, Neutron, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Pre-1976 Neutron Therapy Device, Northern Illinois University Institute for Neutron Therapy at Fermilab: named in the summary without a submission number

## Indications for use
The NTS is a preamendments medical device designed to produce and deliver a neutron beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Source page: https://510kreport.com/device/K063691
Methodology: https://510kreport.com/methodology