Taiwan FDA registration a7afeb5d9a78def907a8146f0765e87c
“PHILIPS”Philips IntelliSite Pathology Solution
TW: “飛利浦”數位病理系統
Taiwan·Risk Class 2·MD·Philips Medical Systems Nederland B.V.·Registered Apr 02, 2019 – Apr 02, 2024ExpiredRegistration details
- Analysis ID
- a7afeb5d9a78def907a8146f0765e87c
- License Form
- Ministry of Health Medical Device Import No. 032394
- Customs Code
- DHA05603239402
Company information
- Manufacturer
- Philips Medical Systems Nederland B.V.
- Manufacturer Country
- Netherlands
- Authorized Representative
- PHILIPS TAIWAN LIMITED
Product details
- Intended Use
- 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.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B1860 Immunopathological histochemical reagents and kits
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Apr 02, 2019
- Expiry Date
- Apr 02, 2024
About this record
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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