South Korea MFDS registration In Vitro Water No. 23-197
Pathology Tissue Diagnosis Assistant Software II
KO: 병리조직진단보조소프트웨어II
South Korea·Unknown·Roche Diagnostics Korea·Approved May 03, 2023Basic information
- Item Serial Number
- 2023002621
- License Number
- In Vitro Water No. 23-197
- Classification Number
- P04010.01
- Device Class (Risk Classification)
- Unknown
- Classification Name
- Pathology Tissue Diagnosis Assistant Software II
- Official English Name
- Computer aided diagnosis software for pathological cells or tissue
체외수허23-197호
병리조직진단보조소프트웨어II
Company information
- Category
- In vitro diagnostic import business
- Business License Number
- 체외 제 730 호
체외진단수입업
Important dates & status
- Item Approval Date
- May 03, 2023
- Business Permit Date
- May 27, 2005
- Expiration Period
- 2023-05-03 ~ 2028-05-02
Model information
- Model Name
- uPath PD-L1 (SP263) image analysis for NSCLC Algorithm
About this record
This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In Vitro Water No. 23-197. Approved on May 03, 2023. Registered by Roche Diagnostics Korea.
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