Himaging Technology (Shanghai) Co., Ltd. · Class II · Cleared Sep 23, 2025
| K-number | K251894 |
| Device name | Himaging Bronchscope System |
| Applicant | Himaging Technology (Shanghai) Co., Ltd. |
| Product code | EOQ |
| Device class | Class II |
| Decision date | Sep 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 874.4680 |
The Himaging Bronchoscope System is a sterile, single-use flexible video bronchoscope designed for endoscopic examination and procedures within the airways and tracheobronchial tree in adults. It is used in hospital environments in conjunction with the Himaging endoscopic video processor, monitor, and ancillary endoscopy equipment.
The subject device includes a flexible video bronchoscope (DBRS-100HLP) with a 5.8mm maximum outer diameter, 2.0mm working channel, 100° field of view, 2–100mm depth of field, and a desk-type endoscopic video processor (HDIS-1000) without an integrated LCD display. Key differences from the predicate include a higher field of view (100° vs 85°), greater depth of field range (2–100mm vs 8–19mm), manual white balance function, DVI video output, and external power supply only rather than dual internal/external power modes.
ISO 8600-1:2015, ISO 8600-3:2019, ISO 8600-4:2014, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-10:2021, IEC 60601-1:2005+AMD, IEC 60601-2-18:2009, IEC 60601-1-2:2014+AMD, IEC 62471:2006, ASTM F1980-2016, ASTM F88/F88M-21, ASTM F1929-15, ASTM F1886/F1886M-16, ASTM D4169-22, CIE ISO 11664-2:2022, CIE ISO 11664-6:2022.
The device is substantially equivalent because it performs the same intended function (bronchoscopic examination within airways and tracheobronchial tree) and shares the same product code, regulation, and classification as the predicate. Although the endoscopic video processor differs in physical form factor and some features (no integrated monitor, different zoom/white balance/power modes, DVI output), quantitative image quality testing (color reproduction, geometric distortion, intensity uniformity, depth of field, resolution) demonstrates equivalent optical performance. The bronchoscope shares identical working channel diameter, length, and sterilization method; minor differences in bending angle, field of view, and depth of field do not affect safety or effectiveness per design and functional testing per ISO standards. Biocompatibility, electrical safety, EMC, and sterilization all comply with applicable standards and show no adverse safety profile.
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