2430TCA with Xmaru W

The 2430TCA is a digital flat-panel X-ray detector based on TFT photodiode array technology with a CsI scintillator, designed for mammographic screening. It captures and digitalizes X-ray images for breast screening, replacing film-based mammography systems, and works with the Xmaru W software for image processing and viewing.

The 2430TCA uses a TFT photodiode array (versus the predicate's CMOS array) with identical CsI:Tl scintillator, similar imaging area (227.3 × 289.0 mm vs. 231.8 × 304.0 mm), similar pixel pitch (74 µm vs. 70 µm), and 16-bit A/D conversion (versus 14-bit in predicate). Both employ the same indirect radiation detection method and comparable MTF and DQE performance.

IEC 60601-1:2005 AMD1:2012 AMD2:2020 (electrical safety), IEC 60601-1-2:2014+AMD1:2020 (EMC), IEC 62220-1-2 (detective quantum efficiency for mammography detectors), and FDA guidance for Full Field Digital Mammography Systems and software in medical devices.

The 2430TCA demonstrates substantial equivalence because it has identical indications for use, the same scintillator material (CsI:Tl), comparable imaging performance metrics (MTF, DQE, NPS), and MQSA-certified radiologists confirmed equal or better image quality compared to the predicate 2430MCA. Clinical review found acceptable screening image quality from both devices, and non-clinical testing using identical equipment and IEC 62220-1 methods showed equivalent or superior diagnostic image quality, with differences in detector type and A/D resolution not raising new safety or effectiveness concerns.