510(k) · Cleared
ClearedFlexBoardTM, EagleBoardTM, BreastBoard SXTM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Macromedics BV · IYE Accelerator, Linear, Medical
Cleared on Jun 24, 2022 as substantially equivalent to K211001 (Medtec, Inc. Dba Civco Medical Solutions and Civco, 2021) and 1 other predicate after a 242-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Jun 24, 2022
- Review
- 242 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K905007 (1991). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK905007 Standard Breast Boards; Deluxe Breast BoardBionix Development Corp. · 1991
- 5 generations backK030051 Versaboard, Model 7040Bionix Development Corp. · 2003
- 4 generations backK060737 Sinmed Positioning DevicesSinmed BV · 2006
- 3 generations backK093738 Mri Patient Positioning DevicesMedtec, Inc. · 2010
- 2 generations backK111340 Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011
- 1 generation backK142420 Patient Positioning DevicesMacromedics BV · 2015
- This deviceK213439 FlexBoardTM, EagleBoardTM, BreastBoard SXTMMacromedics BV · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K905007 | Standard Breast Boards; Deluxe Breast Board | Bionix Development Corp. | 1991 | — |
| −5 | K030051 | Versaboard, Model 7040 | Bionix Development Corp. | 2003 | — |
| −4 | K060737 | Sinmed Positioning Devices | Sinmed BV | 2006 | — |
| −3 | K093738 | Mri Patient Positioning Devices | Medtec, Inc. | 2010 | — |
| −2 | K111340 | Head and Neck Immobilization System, Body Immobilization System | Medtec, Inc. | 2011 | — |
| −1 | K142420 | Patient Positioning Devices | Macromedics BV | 2015 | — |
| 0 (this device) | K213439 | FlexBoardTM, EagleBoardTM, BreastBoard SXTM | Macromedics BV | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211001 | C-Qual M™ Breastboard; Monarch™ Overhead Arm PositionerSummary page 5…claimed Page | 1 K211001 C-Qual M™ MEDTEC, Inc. d/b/a “CIVCO FlexBoard™ Breastboard; Medical… | 2021 |
| * | K142420 | Patient Positioning DevicesSummary page 5…Medical Solutions” and EagleBoard™ Monarch™ Overhead “CIVCO Arm Positioner Radiotherapy” K142420 BreastBoard LX™ MacroMedics BV BreastBoard SX™ 4. Subject Device Description, Intended… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 20 ancestors have a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
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…
Read the full statement (161 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213439 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213439: FlexBoardTM, EagleBoardTM, BreastBoard SXTM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213439
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026