Taiwan FDA registration ab2d743383b86d9ac85a6e80e29771c1

“CYBERNET” Diagnosis support program for endoscope images

TW: “莎易博”內視鏡影像瘜肉輔助偵測軟體

Taiwan·Risk Class 2·MD·Cybernet Systems Co., Ltd.·Registered Apr 25, 2022 – Apr 25, 2027Active

Registration details

Analysis ID: ab2d743383b86d9ac85a6e80e29771c1
License Form: Ministry of Health Medical Device Import No. 035256
Customs Code: DHA05603525605

Company information

Manufacturer: Cybernet Systems Co., Ltd.
Manufacturer Country: Japan
Authorized Representative: YUAN LI INSTRUMENT CO., LTD.

Product details

Intended Use: 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.).
Product Type (Level 1): H Gastroenterology and urology
Product Type (Level 2): H9999 Other
Import Information: Imported from abroad

Dates and status

Registration Date: Apr 25, 2022
Expiry Date: Apr 25, 2027

About this record

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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