# K213439: FlexBoardTM, EagleBoardTM, BreastBoard SXTM

- Pathway: 510(k) (Traditional)
- Applicant: Macromedics BV
- Decided: Jun 24, 2022 after 242 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: 6 generations back to K905007 (1991). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211001: C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner, Medtec, Inc. Dba Civco Medical Solutions and Civco (2021) Summary page 5.
- K142420: Patient Positioning Devices, Macromedics BV (2015) Summary page 5.

## Indications for use
The FlexBoardTM is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, proton, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) imaging systems. The EagleBoardTM is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, proton, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems. The BreastBoard SXTM is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, proton, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) imaging systems.

Source page: https://510kreport.com/device/K213439
Methodology: https://510kreport.com/methodology