UL UHD-Clear View 4K Camera System (UL-3Chip 4K)

The UL UHD-Clear View 4K Camera System is a medical imaging device consisting of a Camera Control Unit (CCU) and Endoscopic Camera Head that connects to external medical-grade display monitors. It provides 4K resolution video output for visualization during general endoscopic procedures to support diagnostic or therapeutic interventions of internal anatomical structures.

The device uses CMOS sensor technology with 3840×2160p resolution, includes adaptive zoom and 12G/3G-SDI display ports, and features two additional HDMI ports. Both the subject and predicate devices share the same sensor resolution and CMOS-based architecture, though the subject device offers additional HDMI connectivity compared to the Karl Storz predicate.

IEC 60601-1:2005 + AMD1:2012 + AMD2:2020 (Medical Electrical Equipment—General Requirements for Basic Safety and Essential Performance); IEC 60601-1-2:2014 + AMD1:2020 (Electromagnetic Disturbances); IEC 60601-2-18:2009 (Particular requirements for endoscopic equipment). Software verification and validation testing was performed per Content of Premarket Submissions for Device Software Functions (Moderate Level of Concern).

The subject device has substantially similar indications for use and technological characteristics to the Karl Storz Image1 S CCU predicate device, both providing endoscopic visualization using CMOS sensor technology at 3840×2160p resolution. Non-clinical testing including bench testing, electromagnetic compatibility, and electrical/mechanical/thermal safety demonstrates the subject device is as safe and effective as the predicate. The minor differences—additional HDMI ports and labeling clarifications—do not raise different safety or effectiveness questions and fall within the predicate's intended scope.