Taiwan FDA registration 1e0e4038fbdb9dca4f032f02eee4893f

“CYBERNET” Diagnosis support software for endoscope images

TW: “莎易博”內視鏡大腸病變影像輔助診斷軟體

Taiwan·Risk Class 2·MD·Cybernet Systems Co., Ltd.·Registered May 11, 2022 – May 11, 2027Active

Registration details

Analysis ID: 1e0e4038fbdb9dca4f032f02eee4893f
License Form: Ministry of Health Medical Device Import No. 035259
Customs Code: DHA05603525901

Company information

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

Product details

Intended Use: This product analyzes the 520x magnification of colorectal lesions captured by endoscope (CF-H290ECI), and provides predictive information for pathological diagnosis to assist physicians in reading images. The endoscopic image is input to the computer through the SDI line, and the pattern recognition and analysis of artificial intelligence is carried out through the feature values extracted by image texture analysis, and the classification reliability of tumor (Neoplastic) or non-tumor (Non-neoplastic) is displayed.
Product Type (Level 1): H Gastroenterology and urology
Product Type (Level 2): H9999 Other
Import Information: Imported from abroad

Dates and status

Registration Date: May 11, 2022
Expiry Date: May 11, 2027

About this record

Access comprehensive regulatory information for “CYBERNET” Diagnosis support software 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 1e0e4038fbdb9dca4f032f02eee4893f and manufactured by Cybernet Systems Co., Ltd.. The authorized representative in Taiwan is YUAN LI INSTRUMENT CO., LTD..

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