Digital Radiography System (ManntiX B, ManntiX K)

The Digital Radiography System (ManntiX B and ManntiX K) is a portable digital X-ray device intended for use by qualified physicians or technicians to acquire X-ray images of patient anatomy including head, cervical spine, chest, abdomen, lumbar spine, pelvis, and extremities. The system is not intended for mammography or pediatric patients.

The proposed device features a portable X-ray assembly (PX10 or PX10 Pro), multiple digital detectors (Mars1717X, CareView 1500Cwe, or Luna 1012X with varying sizes and pixel pitches), tube voltage of 40–125 kV with 1 kV steps, mAs ranges up to 360 mAs (AC) or 80 mAs (DC), wireless and wired communication (IEEE 802.11a/b/g/n/ac), and image processing software (MOC V03) with annotation, measurement, and DICOM 3.0 compatibility.

IEC 60601-1 (general safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-1-3 (radiation protection in diagnostic X-ray), IEC 60601-2-54 (X-ray equipment for radiography and radioscopy), ISO 10993-1 (biological evaluation), IEC 62304 (software life cycle), and IEC 62366-1 (usability engineering).

The proposed device shares the same intended use, regulatory classification (Class II mobile X-ray system), and fundamental technological approach as the predicate SR-2300/SR-2300S. Both employ portable X-ray assemblies with similar voltage and current ranges, removable digital detectors with amorphous silicon scintillators, wireless and wired connectivity, and comparable image processing and storage capabilities. The differences in detector options, mAs range extensions, and wireless protocol updates (802.11ac support) do not introduce new safety or effectiveness issues, as these represent incremental technological improvements within the same functional platform.