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“CYBERNET” Diagnosis support program for endoscope images - Taiwan Registration ab2d743383b86d9ac85a6e80e29771c1

Access comprehensive regulatory information for “CYBERNET” Diagnosis support program for endoscope images in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ab2d743383b86d9ac85a6e80e29771c1 and manufactured by Cybernet Systems Co., Ltd.. The authorized representative in Taiwan is YUAN LI INSTRUMENT CO., LTD..

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ab2d743383b86d9ac85a6e80e29771c1
Registration Details
Taiwan FDA Registration: ab2d743383b86d9ac85a6e80e29771c1
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Device Details

“CYBERNET” Diagnosis support program for endoscope images
TW: “莎易博”內視鏡影像瘜肉輔助偵測軟體
Risk Class 2
MD

Registration Details

ab2d743383b86d9ac85a6e80e29771c1

Ministry of Health Medical Device Import No. 035256

DHA05603525605

Company Information

Product Details

This product is a computer-aided detection (CADe) program. A reasoning model generated by machine learning (learning data) using a large number of endoscopic images detects and reveals the possibility of colorectal lesions (polyps, etc.). In the process of routine endoscopic examination of whether there is polyps, when this product finds foci such as polyps, it will emit a warning sound and display colors in the four corners of the endoscope display area to remind the doctor to pay attention to auxiliary diagnosis. Therefore, this product is only positioned as an "auxiliary physician", and is not used alone for screening or diagnosis of colorectal lesions (polyps, etc.).

H Gastroenterology and urology

H9999 Other

Imported from abroad

Dates and Status

Apr 25, 2022

Apr 25, 2027