Olympus Corporations of the Americas · Class II · Cleared Apr 2, 2025
| K-number | K242067 |
| Device name | VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA |
| Applicant | Olympus Corporations of the Americas |
| Product code | FET |
| Device class | Class II |
| Decision date | Apr 2, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The VISERA ELITE III Surgical Imaging System is a three-component endoscopic video imaging system consisting of a video system center (OTV-S700) that processes electronic signals from video endoscopes or camera heads and outputs image to a monitor, a LED light source (CLL-S700) that provides illumination to endoscopes, and a 4K camera head (CH-S700-XZ-EA) for capturing high-resolution images. The system is intended for endoscopic diagnosis, treatment, and observation of internal organs.
The OTV-S700 operates at AC 100-240V (versus predicate's AC 100V), has lower power input (<170VA vs 400VA), and is physically smaller and lighter. It adds HDR observation and optional 3D capability via accessory MAJ-2511. The CLL-S700 light source is standalone without front panel controls. The CH-S700-XZ-EA camera head uses single 1 CMOS sensor with 4K resolution (12.7 megapixels) versus the predicate's 3 CMOS with 2.1 megapixels, features automatic focus capability, optical transmission, and Type CF protection against electric shock.
ISO 15223-1, ISO 7000, ISO 7010, ANSI AAMI ST98:2022, ISO 17664-2, ISO 17665-1, ANSI AAMI IEC 62304:2006, IEC 81001-5-1, AAMI TIR57:2016, ANSI AAMI ES 60601-1:2005, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, ISO 8600-1, ISO 8600-3, IEC 62471:2006, IEC 60825-1, and ISO 14971:2019.
Olympus argues substantial equivalence based on identical intended use (endoscopic diagnosis, treatment, observation), identical principles of operation and fundamental technology compared to predicates OTV-S300 (K201200) and CH-S200-XZ-EA (K190449), and no introduction of new treatments or standards of care. Specification differences (voltage, dimensions, weight, HDR, 3D via accessory, higher pixel count, automatic focus) are characterized as enhancements that do not raise new safety risks. Bench testing confirmed equivalent electrical performance in field of view, resolution, brightness, color, latency, and safety parameters. Risk-based assessment concluded these differences do not identify new or significantly modified risks.
View the full FDA submission: accessdata.fda.gov