ULTRA 1040

The ULTRA 1040 is a portable X-ray system intended for use by qualified physicians or technicians to acquire X-ray images of patient extremities. It consists of an X-ray main unit, exposure hand switch, battery charger, and operates with an X-ray detector and image processing software. The device is not intended for mammography.

The ULTRA 1040 uses a lithium polymer battery (58.8 VDC, 250 exposures per charge) compared to the predicate's lithium-ion battery (29.6 VDC, 300 exposures). It operates at 40–100 kVp with tube currents ranging 40–50 mA down to 20 mA at higher voltages, similar to the predicate. Exposure times range 0.008–2.5 seconds versus the predicate's 0.02–2.5 seconds. The ULTRA 1040 has 10 memory settings versus 5 on the predicate, and a slightly higher output power of 2.4 kW versus 2.0 kW. It uses a different X-ray tube (OX/100-L) and collimator design.

Testing performed per IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-54, IEC 60601-1-2 (EMC), IEC 62133-2 (lithium battery safety), IEC 62304 (software lifecycle), 21 CFR 1020.30 (diagnostic X-ray systems), and 21 CFR 1020.31 (radiographic equipment). Bench performance testing assessed radiation performance, collimator accuracy, battery performance, imaging quality, and safety.

Both devices are mobile X-ray systems with the same product code (IZL), regulation (21 CFR 892.1720), and intended principle of operation (general purpose diagnostic X-ray). While the ULTRA 1040 narrows its indication to extremities only versus the predicate's broader anatomical scope, the submission argues this does not constitute a new intended use—it is simply a subset of the predicate's capabilities. The tube voltage range, current profiles, and exposure times are similar. Differences in collimator design, X-ray tube type, battery specifications, and field size are characterized as inherent design variations that do not significantly affect performance. Comprehensive testing demonstrating compliance with the same safety and performance standards as the predicate supports functional equivalence.