Singapore HSA registration DE0510331
Medipixel Cardiovascular Image Analysis Software
Singapore·CLASS B·Medipixel, Inc.·Registered February 12, 2025Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0510331
- Registration Date
- February 12, 2025
- Retention Due Date
- February 11, 2026
Product description
MPXA-2000 is software intended to be used for performing calculations in X-ray angiographic images of the coronary arteries. These calculations are based on vessel contours which are automatically detected by the software and subsequently presented for review and manual editing. The analysis results obtained with MPXA-2000 are intended for use by cardiologists and radiologists: - to support clinical decisions concerning the coronary arteries. - to support the evaluation of intervention or drug therapy applied for conditions of the coronary arteries
Product Owner
- Name
- Medipixel, Inc.
- Short Name
- Medipixel, Inc.
- Address
- Seokyung Building 3F, 22, Teheran-ro 108-gil,, Gangnam-gu, Seoul, KOREA, REPUBLIC OF
Registrant
- Name
- ARQON PTE. LTD.
- Address
- 221 HENDERSON ROAD, HENDERSON BUILDING, #02-08, SINGAPORE 159557
Model information
- Model Name(s)
- Cardiovascular Image Analysis Software
- Model Identifier(s)
- MPXA-2000
About this record
Access comprehensive regulatory information for Medipixel Cardiovascular Image Analysis Software in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510331 and owned by Medipixel, Inc.. The device was registered on February 12, 2025.
This page provides complete registration details including product owner information, registrant details, 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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