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Singapore HSA registration DE0012319

Infinitt Xelis Picture Archiving Communication System (PACS)

Singapore flagSingapore·CLASS C·Infinitt Healthcare Co. Ltd·Registered February 08, 2013
Device classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration information
Registration Number
DE0012319
Registration Date
February 08, 2013
Retention Due Date
February 07, 2026
Product description
XELIS PACS is intended for viewing and manipulating DICOM compliant medical images from CT (computerized tomography), PET (positron emission tomography) or MR (magnetic resonance imaging) scanners and other imaging modalities. XELIS can be used for real-time viewing, 3D volume rendering, segmentation, registration, and reporting. Xelis has several modules which can be used as a dedicated solution for various departments. It includes specialized modules such as Colon, Cardiac, Lung, Dental, Perfusion, and Fusion.
Product Owner
Name
Infinitt Healthcare Co. Ltd
Short Name
Infinitt
Address
12F Daerung Post Tower III 182-4, Guro-dong, Guro-Gu, Seoul, Korea 152-050, 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 Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552 211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Model information
Model Name(s)
Xelis Dental Xelis 3D Xelis Cardiac Xelis Colon Xelis Fusion Xelis Lung Xelis Perfusion
Model Identifier(s)
1.0.5.0 (Dental) 1.0.5.1 (3D) 1.0.5.1 (Cardiac) 1.0.5.1 (Colon) 1.0.5.1 (Fusion) 1.0.5.1 (Lung) 1.0.5.1 (Perfusion)
About this record

Access comprehensive regulatory information for Infinitt Xelis Picture Archiving Communication System (PACS) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0012319 and owned by Infinitt Healthcare Co. Ltd. The device was registered on February 08, 2013.

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 C