Circle Cardiovascular Imaging旗下信息化軟件類產品獲FDA批准，註冊證號為K251027

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2025/11/18

產品名稱：cvi42 Coronary Plaque Software Application，所屬單位：Circle Cardiovascular Imaging，產品類型：信息化軟件，產品詳情：cvi42 Coronary Plaque Software Application是一款軟件即醫療器械，可用於分析心臟冠狀動脈的計算機斷層掃描血管造影（CTA）圖像。該軟件旨在通過手動或半自動分割...

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overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nCircle Cardiovascular Imaging旗下信息化軟件類產品獲FDA批准，註冊證號為K251027\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">動脈網</strong><span class=\"h-time small\">2025-11-18 17:43</span>\n</p>\n</h4>\n</header>\n<article>\n<div>\n<p>產品名稱：cvi42 Coronary Plaque Software Application，所屬單位：Circle Cardiovascular Imaging，產品類型：信息化軟件，產品詳情：cvi42 Coronary Plaque Software Application是一款 軟件即醫療器械，可用於分析心臟冠狀動脈的計算機斷層掃描血管造影（CTA）圖像。該軟件旨在通過手動或半自動分割...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN202511181744299770de2c&s=b\">網頁鏈接</a>\n\n</div>\n\n<div class=\"bt-text\">\n\n\n<p> 來源：<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN202511181744299770de2c&s=b\">動脈網</a></p>\n<p>為提升您的閱讀體驗，我們對本頁面進行了排版優化</p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU1791807156.HKD","symbol_name":"BGF WORLD FINANCIALS \"A2\" (HKDHDG) ACC","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN202511181744299770de2c&s=b","article_id":"2584933381","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN202511181744299770de2c&s=b","rn_cache_url":null,"customStyle":"body{padding-top:10px;}#news_title{font-weight:bold;#titleStyle#;}#news_description span{font-size:12px;#descriptionStyle#;}.footer-note{#statement#}","selectors":".mod-LoadTzbdNews, body","filters":".relate-stock, .hot-list, .recom-box, .wx-sou","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2584933381","pubTimestamp":1763458980,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"產品名稱：cvi42 Coronary Plaque Software Application，所屬單位：Circle Cardiovascular Imaging，產品類型：信息化軟件，產品詳情：cvi42 Coronary Plaque Software Application是一款 軟件即醫療器械，可用於分析心臟冠狀動脈的計算機斷層掃描血管造影圖像。審批機構：FDA，證件類型：二類，註冊證編號：K251027，獲批時間：2025-10-27","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"LU1791807156.HKD":"BGF WORLD FINANCIALS \"A2\" (HKDHDG) ACC","LU1861217088.USD":"贝莱德金融科技A2","BK4023":"应用软件","LU0106831901.USD":"贝莱德世界金融基金A2","LU2360107671.USD":"BGF FINTECH \"A4\" (USD) INC","LU1861220207.SGD":"Blackrock FinTech A2 SGD-H","LU1668664300.SGD":"Blackrock World Financials A2 SGD-H","CTA":"SIMPLIFY MANAGED FUTURES STRATEGY ETF","CRCL":"Circle Internet Corp."},"translate_title":"Circle Cardiovascular Imaging's information software products have been approved by the FDA with registration number K251027","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CRCL":0.9,"CTA":1},"content_text":"產品名稱：cvi42 Coronary Plaque Software Application，所屬單位：Circle Cardiovascular Imaging，產品類型：信息化軟件，產品詳情：cvi42 Coronary Plaque Software Application是一款 軟件即醫療器械，可用於分析心臟冠狀動脈的計算機斷層掃描血管造影（CTA）圖像。該軟件旨在通過手動或半自動分割血管管腔與血管壁，輔助醫師對冠狀動脈斑塊進行可視化觀察、評估與分析，從而判斷接受冠狀動脈計算機斷層掃描血管造影（CCTA）檢查（用於評估冠心病或疑似冠心病）的患者體內冠狀動脈斑塊及管腔狹窄的存在情況與嚴重程度。審批機構：FDA，證件類型：二類，註冊證編號：K251027，獲批時間：2025-10-27","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}