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Singapore HSA registration DE0504392

Infinitt Healthcare INFINITT PACS 7.0

Singapore flagSingapore·CLASS B·Infinitt Healthcare Co. Ltd.·Registered April 24, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0504392
Registration Date
April 24, 2020
Change Notification Approval Date
August 13, 2024
Retention Due Date
April 23, 2026
Product description
Infinitt PACS 7.0 is a software device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Product Owner
Name
Infinitt Healthcare Co. Ltd.
Short Name
Infinitt Healthcare Co. Ltd.
Address
12F, Daerung Post Tower III,, 27 Digital-ro 34-gil, Guro-gu, Seoul 08378, KOREA, REPUBLIC OF
Registrant
Name
Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Name
Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552
Model information
Model Name(s)
Infinitt PACS 7.0
Model Identifier(s)
INFINITT PACS 7.0
About this record

Access comprehensive regulatory information for Infinitt Healthcare INFINITT PACS 7.0 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504392 and owned by Infinitt Healthcare Co. Ltd.. The device was registered on April 24, 2020.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B