# K112981: Sun 125C Ionization Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Sun Nuclear Corp.
- Decided: Jan 25, 2012 after 111 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: 2 generations back to K954165 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972212: 0.015CC Pinpoint Ionization Chamber, 0.005 CC Pinpoint Ionization Chamber, Ptw-New York Corp. (1997) Summary page 1.

## Indications for use
The Ionization Chamber model 1041 is intended for the purpose of calibrating and measuring the ionizing radiation output from medical radiation therapy machines. This includes beam scanning as well as absolute dose calibration.

Source page: https://510kreport.com/device/K112981
Methodology: https://510kreport.com/methodology