Singapore HSA registration DE0508971
AI Medical Endoscopic Image Diagnosis Support Software - gastroAI-model G
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0508971
- Registration Date
- February 19, 2024
- Retention Due Date
- February 18, 2026
Product description
The gastroAI-model G system analyzes gastric endoscopic images acquired by observers for the purpose of disease differentiation of lesions suspected of epithelial tumors (adenomas and adenocarcinoma) arising from the gastric mucosa, and identifies neoplastic lesions based on the visual characteristics of the lesions. The positioning of this system is to assist observers in distinguishing between tumor and nontumor diseases. The gastroAI-model G is intended to detect neoplastic lesions indicated for Endoscopic Submuscosal Dissection (ESD), and the disease states are Gastric Cancer (Type 0-I, 0-IIa, 0-IIb and 0-IIc) and Gastric Adenoma. The gastroAI-model G system is not intended to identify neoplastic lesions not indicated for ESD, specific or special lesions such as raspberry like glandular epithelium type gastric cancer and non- neoplastic lesions. It is not intended to make a definitive diagnosis based solely on the analysis results of this system.
Product Owner
- Short Name
- AI Medical Service Inc.
- Address
- Hareza Tower 11F, 1-18-1, Higashi-Ikebukuro, Toshima-ku, Tokyo, 170-0013, JAPAN
Registrant
- Address
- 42 KIM YAM ROAD, OLEANAS RESIDENCE, #19-02, SINGAPORE 239347
Importer
- Address
- 18 ANN SIANG ROAD, #02-01, SINGAPORE 069698 160 ROBINSON ROAD, SINGAPORE BUSINESS FEDERATION CENTER, #14-04, SINGAPORE 068914
Model information
- Model Name(s)
- Endoscopic image diagnosis support software - gastroAI-model G
- Model Identifier(s)
- 999
About this record
Access comprehensive regulatory information for AI Medical Endoscopic Image Diagnosis Support Software - gastroAI-model G in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508971 and owned by AI Medical Service Inc.. The device was registered on February 19, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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