# K211001: C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner

- Pathway: 510(k) (Traditional)
- Applicant: Medtec, Inc. Dba Civco Medical Solutions and Civco
- Decided: May 20, 2021 after 48 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: 2 generations back to K973842 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180021: Proton Positioing and Immobilization Devices, Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap (2018) Summary page 4.

## Most influential descendants
- K213439: FlexBoardTM, EagleBoardTM, BreastBoard SXTM (2022), 0 descendants of its own

## Indications for use
The device is indicated to aid in supporting and positioning adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon, and proton treatments. 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 device is not intended for use with patients under 12 years of age.

Source page: https://510kreport.com/device/K211001
Methodology: https://510kreport.com/methodology