# K982937: Model 580-006 Radiation Therapy Ionization Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Victoreen, Inc.
- Decided: Nov 19, 1998 after 90 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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 K932342 (1993). 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)
- K932342: Model 500-6 Radiation Therapy Ionization Chamber, Victoreen, Inc. (1993) Summary page 1.

## Indications for use
This instrument is intended for the purpose of calibrating and measuring the ionizating radiation outputs for medicas therapy machines.

Source page: https://510kreport.com/device/K982937
Methodology: https://510kreport.com/methodology