Singapore HSA registration DE0508688
Hologic Genius AI Detection software
Singapore·CLASS B·Hologic, Inc·Registered November 23, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0508688
- Registration Date
- November 23, 2023
- Retention Due Date
- November 22, 2025
Product description
Genius AI Detection software is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthesis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions, and asymmetries) and calcifications in DBT exams from compatible DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score. The device intends to aid in the interpretation of digital breast tomosynthesis exams in a concurrent fashion, where the interpreting physician confirms or dismisses the findings during the reading of the exam.
Product Owner
- Name
- Hologic, Inc
- Short Name
- Hologic, Inc
- Address
- 36, Apple Ridge Rd, Danbury, CT 06810, UNITED STATES
Registrant
- Address
- 219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Importer
- Address
- 219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Model information
- Model Name(s)
- Genius AI Detection
- Model Identifier(s)
- Genius AI Detection
About this record
Access comprehensive regulatory information for Hologic Genius AI Detection 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 DE0508688 and owned by Hologic, Inc. The device was registered on November 23, 2023.
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.
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