Prone Breast Positioning Board, Model #37-018

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K971382 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the Prone Breast Positioning Board Model #37-018 used for?

  The Prone Breast Positioning Board is a linear accelerator couch-mounted platform designed to position the breast in a gravity-dependent orientation during radiation therapy. It facilitates breast-conserving therapy for patients with large or pendulous breasts by improving dose homogeneity and reducing treatment complications.

• How is the Prone Breast Positioning Board supplied?

  The device is supplied as a single unit and is intended for use with linear accelerators in radiation therapy applications. It is operated by radiation therapists in clinical radiation oncology settings.

• What is the regulatory status of the Prone Breast Positioning Board Model #37-018?

  The device is a Class II medical device with FDA 510(k) clearance (K971382) issued on June 6, 1997, and is classified under product code IYE. It has been determined to be substantially equivalent to predicate devices.

• Is the Prone Breast Positioning Board reusable or single-use?

  The device is supplied as a single unit, but the description does not specify whether it is designed for single-use or multiple uses. For specific reuse instructions, users should consult the manufacturer's guidelines and facility protocols.