開立醫療(300633.SZ)申報醫療器械註冊獲得批准 涉4K超高清醫用內窺鏡攝像系統
格隆匯 1 月 21日丨開立醫療(300633.SZ)公佈,公司的4K超高清醫用內窺鏡攝像系統已獲廣東省藥品監督管理局批准,於近日取得中華人民共和國醫療器械註冊證,證書批准日期為:2021年01月19日,有效期至:2026年01月18日,註冊證編號:粵械注準20212060089。
該醫療器械產品目前已完成第二類醫療器械註冊證核發,並取得了《中華人民共和國醫療器械註冊證》。
隨着內窺鏡微創技術的普及和內窺鏡加工工藝的提高,內窺鏡應用已涉及外科、耳鼻喉科、婦產科等科室,成為不可或缺的醫用診斷和手術設備,也是全球醫療器械產業中增長較快的產品之一。
國內內窺鏡市場長期被外資品牌壟斷,外資品牌憑藉成熟的技術和完善的營銷管理體系,在內窺鏡市場較早得到了消費者的認可。雖然中國品牌在價格上有絕對優勢,但技術水平仍然是軟肋,加之銷售渠道的開拓能力及售後維修能力有限,市場佔有率不到四分之一。
SV-M4K30 4K超高清醫用內窺鏡攝像系統採用低功耗3CMOS超高清圖像傳感芯片,輸出視頻圖像最大分辨率不低於3840×2160像素(4K),超清畫質,纖毫畢現。SV-M4K30採用自主開發的圖像處理算法,圖像畫質更清晰;支持BT2020廣色域顯示,色彩呈現更逼真;視頻幀率達到60fps,調光迅速準確無拖影,顯著緩解術者眼部疲勞;電子染色技術與腔鏡照明用多波長LED光源聯動,實現多種特殊光成像功能,支持腹腔、胸腔、宮腔、泌尿、關節、耳鼻喉等全外科手術模式,滿足不同臨牀診療需求,適用於1-4級全級別手術。
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