VIVIX-M

VIVIX-M is a series of flat panel digital detectors (models FXMD-2430S and FXMD-1008S) used in mammography to acquire digital images for screening and diagnosis. The detectors intercept x-ray photons, which are converted to visible light by a cesium iodide scintillator, then captured by photodiode arrays and converted to digital images. The system integrates with an x-ray generator and operates with VXvue Mammo software for image processing and DICOM transmission.

Both VIVIX-M models use thallium-doped cesium iodide scintillator material with a pixel pitch of 75 micrometers and 3072×3840 (FXMD-2430S) or 3072×2304 (FXMD-1008S) pixel matrices. The devices operate on DC +24V power with lower power consumption (18W max) compared to the predicate's 30W. MTF and DQE performance metrics are comparable or superior to the predicate across tested spatial frequencies, demonstrating equivalent spatial resolution and signal-to-noise efficiency.

Testing complied with IEC 62220-1-2:2007 (Medical Electrical Equipment – Characteristics of Digital X-Ray Imaging Devices), IEC 60601-1 and IEC 60601-1-2, MQSA average glandular dose requirements, and FDA's Class II Special Controls Guidance for Full-Field Digital Mammography Systems (March 27, 2012). Non-clinical testing included MTF, DQE, noise power spectrum, dynamic range, ghosting, AEC performance, and phantom testing (ACR, TE, CDMAM).

The VIVIX-M is substantially equivalent because it maintains identical intended use (screening and diagnostic mammography), operates on the same fundamental principle (x-ray detection via scintillator and photodiode array), and demonstrates equivalent performance metrics to the predicate RSM 2430C across all critical parameters: pixel pitch (75 vs 76 micrometers), pixel matrix dimensions, MTF values (54.9% at 3lp/mm vs predicate 70% at 2lp/mm), and DQE (59.0% at 3lp/mm vs predicate 43% at 2lp/mm). Clinical image evaluation confirmed diagnostic capability equivalent to the predicate, and non-clinical testing per recognized FDA standards showed no significant differences that would adversely affect performance.