# K973960: MODEL 37-185

- Pathway: 510(k) (Traditional)
- Applicant: Victoreen, Inc.
- Decided: Jan 14, 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 K853671 (1986). 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)
- K853671: Beamscan, Victoreen, Inc. (1986) Summary page 1.

## Indications for use
Model 37-18S is used to provide a means of scanning the light field and radiation field generated by radiation therapy machines and presents this data for quality control purposes only. Sequential scans of the light field and the radiation field provides information as to whether the cross hairs in the light field are in the center of the radiation field (per TG-40), the coincidence of the light field to the radiation field, and beam flatness and symmetry. These data aid in the determination of the therapy machine’s performance characteristics.

Source page: https://510kreport.com/device/K973960
Methodology: https://510kreport.com/methodology