K201019 | 合法醫療器材資訊網

2020年11月18日—Trade/DeviceName:GeniusAIDetection.RegulationNumber:21CFR892.2090.RegulationName:Radiologicalcomputerassisteddetectionand ...

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K201019 | 合法醫療器材資訊網

2020年11月18日 — Trade/Device Name: Genius AI Detection. Regulation Number: 21 CFR 892.2090. Regulation Name: Radiological computer assisted detection and ... Read More

Genius AI Detection | 合法醫療器材資訊網

2020年11月18日 — Super Search Devices@FDA 6 ... radiological computer assisted detection/diagnosis software for lesions ... Device Name, Genius AI Detection. Read More

FDA Authorizes Marketing of First Device that Uses Artificial ... | 合法醫療器材資訊網

2021年4月9日 — FDA authorized marketing of the GI Genius, the first device that uses artificial intelligence based on machine learning to detect lesions in ... Read More

FDA Clears Hologic's Genius AI Detection for Breast Cancer | 合法醫療器材資訊網

2020年12月4日 — Hologic, Inc .has announced U.S. Food and Drug Administration (FDA) clearance and commercial availability of the company's Genius AI™ ... Read More

Hologic Receives FDA Clearance for Genius AI Detection | 合法醫療器材資訊網

2020年12月2日 — The new technology represents a pivotal milestone in the early detection of breast cancer, as studies showed Genius AI Detection software aids ... Read More

AI軟體1分鐘測出早期乳腺癌獲FDA批准 | 合法醫療器材資訊網

2020年12月21日 — 美國醫療科技公司Hologic在檢測乳房斷層攝影圖中的潛在癌症病徵方面邁出重要一步，其Genius AI Detection軟體已獲美國食品藥物管理局(FDA)批准。 Read More

Hologic Receives FDA Clearance for Latest Breakthrough in ... | 合法醫療器材資訊網

2020年12月1日 — Hologic Receives FDA Clearance for Latest Breakthrough in Early Breast Cancer Detection, Genius AI™ Detection. Read More

AI軟體1分鐘測出早期乳腺癌獲FDA批准 | 合法醫療器材資訊網

GeniusAI Detection | 合法醫療器材資訊網

Using deep learning technology, Genius AI Detection is designed to find cancers with improved accuracy - the next breakthrough in early breast cancer ... Read More

Genius AI™ Detection Technology | 合法醫療器材資訊網

Using deep learning technology, Genius AI Detection is designed to find cancers with improved accuracy as compared to Hologic's ... FDA Clearance K201019. Read More

相關資訊整理

K201019 | 合法醫療器材資訊網

Genius AI Detection | 合法醫療器材資訊網

FDA Authorizes Marketing of First Device that Uses Artificial ... | 合法醫療器材資訊網

FDA Clears Hologic&#39;s Genius AI Detection for Breast Cancer | 合法醫療器材資訊網

Hologic Receives FDA Clearance for Genius AI Detection | 合法醫療器材資訊網

AI軟體1分鐘測出早期乳腺癌獲FDA批准 | 合法醫療器材資訊網

Hologic Receives FDA Clearance for Latest Breakthrough in ... | 合法醫療器材資訊網

AI軟體1分鐘測出早期乳腺癌獲FDA批准 | 合法醫療器材資訊網

GeniusAI Detection | 合法醫療器材資訊網

Genius AI™ Detection Technology | 合法醫療器材資訊網

FDA Clears Hologic's Genius AI Detection for Breast Cancer | 合法醫療器材資訊網