Medical Monitor (27HS714S)

The 27HS714S is a medical monitor display designed to show color video and images from surgical equipment including laparoscopes, endoscopes, and other medical imaging systems. It features multiple video input ports (DisplayPort, HDMI, DVI, SDI) and can display over 99% of the sRGB color spectrum for use in operating rooms and surgical imaging applications.

The proposed device shares identical indications for use, display technology, power delivery, and video signal standards with the predicate (32HR734S). Minor specification differences include: finer pixel pitch (0.1554 mm vs 0.18159 mm), higher SDI resolution (3840 x 2160 @ 60 Hz), lower maximum power consumption (120 W vs 130 W), and different output ports (DVI-D and DisplayPort instead of HDMI).

IEC 60601-1 Edition 3.2 2020-08 (General requirements for medical electrical equipment safety), IEC 60601-1-2 Edition 4.1 2020-09 (Electromagnetic compatibility), IEC TR 60601-4-2 Edition 1.0 2016-05 (Electromagnetic immunity guidance), and IEC 62304 (Software lifecycle processes). No clinical studies were conducted.

The proposed device meets the same indications for use and core technological specifications as the predicate. All specification differences—pixel pitch, resolution, power consumption, and output ports—are minor and do not affect safe and effective use. Software validation reports and compliance with relevant IEC safety and electromagnetic standards confirm the device performs safely and effectively despite these differences, establishing substantial equivalence based on identical functional purpose and proven safety profile.