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Medipixel Cardiovascular Image Analysis Software - HSA Registration DE0510331

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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CLASS B
DE0510331
Medipixel Cardiovascular Image Analysis Software
HSA Registration Number: DE0510331
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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

Device 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 Owner
Short Name
Medipixel, Inc.
Address
Seokyung Building 3F, 22, Teheran-ro 108-gil,, Gangnam-gu, Seoul, KOREA, REPUBLIC OF
Registrant
Address
221 HENDERSON ROAD, HENDERSON BUILDING, #02-08, SINGAPORE 159557
Model Information
Model Name(s)
Cardiovascular Image Analysis Software
Model Identifier(s)
MPXA-2000