Medical Monitor (32HS710S)

The Medical Monitor (32HS710S) is an LCD display device that shows color video and images from laparoscopic and endoscopic surgical equipment, as well as various medical imaging systems. It features multiple video interface ports including Display Port, HDMI, DVI, and SDI, and can display over 100% of the sRGB color spectrum.

The device differs from its predicate in resolution, video connectors, maximum power consumption, and physical specifications such as weight. Despite these differences, the manufacturer states they do not affect safe and effective use. Performance validation through software testing and safety confirmation via IEC standards were provided to support these claims.

IEC 60601-1 Edition 3.2 (medical electrical equipment general requirements), IEC 60601-1-2 Edition 4.1 (electromagnetic compatibility), IEC TR 60601-4-2 Edition 1.0 (electromagnetic immunity guidance), and IEC 62304 (software validation and verification).

The proposed device shares identical indications for use as the predicate (K241402). Although specifications differ in resolution, connectors, and power consumption, the manufacturer demonstrated through software validation reports and compliance testing with safety standards that these differences do not introduce new safety or effectiveness concerns. Therefore, the device is substantially equivalent because it maintains the same intended clinical purpose with technological variations that have been validated as safe.