# K971382: Prone Breast Positioning Board, Model #37-018

- Pathway: 510(k) (Traditional)
- Applicant: Victoreen, Inc.
- Decided: Jun 6, 1997 after 84 days
- Product code: IYE (Accelerator, Linear, 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 K935411 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935411: Med-Tec, Inc. Breast Board, MT-250, Medtec, Inc. (1994) Summary page 1.

## Most influential descendants
- K102765: Pronex (2010), 0 descendants of its own

## Indications for use
The Prone Breast Positioning Board, model number 37-018 is to be used as a positioning device in patient set-up for primary breast irradiation.

Source page: https://510kreport.com/device/K971382
Methodology: https://510kreport.com/methodology