“PHILIPS”Philips IntelliSite Pathology Solution - Taiwan Registration a7afeb5d9a78def907a8146f0765e87c
Access comprehensive regulatory information for “PHILIPS”Philips IntelliSite Pathology Solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number a7afeb5d9a78def907a8146f0765e87c and manufactured by Philips Medical Systems Nederland B.V.. The authorized representative in Taiwan is PHILIPS TAIWAN LIMITED.
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Device Details
Registration Details
a7afeb5d9a78def907a8146f0765e87c
Ministry of Health Medical Device Import No. 032394
DHA05603239402
Product Details
This product is an automated digital slide creation, viewing and management system. PIPS is suitable for in vitro diagnostic use and is intended to assist pathologists in reviewing and interpreting digital images of surgical pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue; PIPS is not intended for cryosection, cytology, or non-FFPE hematopathology specimens. This product consists of 1) Image Management System (IMS) and 2) Ultra Fast Scanner (UFS) and/or Pathology Scanner SG20/SG60/SG300. This product is designed to scan, create digital images and view slides suitable for manual observation with conventional light microscopes. It is the responsibility of a qualified pathologist to employ appropriate procedures and protective mechanisms to ensure the validity of the image interpretation results obtained using PIPS.
B Hematology and pathology devices
B1860 Immunopathological histochemical reagents and kits
Imported from abroad
Dates and Status
Apr 02, 2019
Apr 02, 2024