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Singapore HSA registration DE0500180

Hologic Cenova Image Analytics Server

Singapore flagSingapore·CLASS B·Hologic Inc.·Registered January 02, 2014
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
HSAMDB00112
HS Code
90189090
Registration information
Registration Number
DE0500180
Registration Date
January 02, 2014
Change Notification Approval Date
December 12, 2024
Retention Due Date
January 01, 2026
Product description
A high-performance application server that provides proprietary software applications to assist radiologists in the analysis of digital mammography images. Cenova is designed to be used by radiologists working in a hospital, outpatient clinic, or a breast imaging center. The server also may be used for research-related activities
Product Owner
Name
Hologic Inc.
Short Name
Hologic Inc.
Address
600 Technology Drive, Newark, DE 19702, UNITED STATES
Registrant
Name
ITS SCIENCE & MEDICAL PTE LTD
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Importer
Name
ITS SCIENCE & MEDICAL PTE LTD
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Model information
Model Name(s)
Quantra License for one 2D FFDM ImageChecker 3D Calc CAD license for one tomosynthesis system ImageChecker CAD License for one 2D FFDM R2 Cenova R2 Cenova R2 Cenova R2 Cenova
Model Identifier(s)
R2LIC-2103-1 R2LIC-2105-CS R2LIC-2111 R2SYS-2100 R2SYS-2100-SW R2SYS-2200 R2SYS-2200-1U
About this record

Access comprehensive regulatory information for Hologic Cenova Image Analytics Server in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500180 and owned by Hologic Inc.. The device was registered on January 02, 2014.

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