FlexBoardTM, EagleBoardTM, BreastBoard SXTM— 510(k) K213439

Name: FDA 510(k) clearance K213439
Creator: U.S. Food and Drug Administration
Published: 2022-06-24

Substantially Equivalent

Macromedics BV

FDA 510(k) clearance K213439 for FlexBoardTM, EagleBoardTM, BreastBoard SXTM, Substantially Equivalent on 2022-06-24. Applicant: Macromedics BV. Device class: 2.

Clearance details

Applicant: Macromedics BV
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2021-10-25
Decision date: 2022-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moordrecht, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYE

view all

K261865 — AerFrame Alignment Laser Box (LBV2)2026-09-16
K261718 — EZFluence (RADEZ V2)2026-08-31
K260733 — MRIA Radiation Therapy Information System (MRIA)2026-08-26
K261856 — Halcyon, Ethos Radiotherapy System (5.0)2026-08-03
K252937 — ThinkQA 32026-06-12

More clearances from Macromedics BV

view all

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.