Singapore HSA registration DE0500391
INVIA Corridor4DM Personal
Singapore·CLASS B·INVIA, LLC.·Registered February 18, 2016Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90181900
Registration information
- Registration Number
- DE0500391
- Registration Date
- February 18, 2016
- Change Notification Approval Date
- January 18, 2024
- Retention Due Date
- February 17, 2026
Product description
INVIA’s Corridor4DM application is intended to provide processing, quantification, and multidimensional review of the biodistribution of radionuclides in the body using planar and tomographic images. The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion emission tomographic images. Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT). The calcium scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, a risk factor for coronary artery disease. Co-registration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation.
Product Owner
- Name
- INVIA, LLC.
- Short Name
- INVIA, LLC.
- Address
- 3025 Boardwalk Drive, Suite 200, Ann Arbor, MI 48108, UNITED STATES
Registrant
- Address
- 1 HARBOURFRONT PLACE, HARBOURFRONT TOWER ONE, #11-01-03, SINGAPORE 098633
Importer
- Address
- 62 UBI ROAD 1, OXLEY BIZHUB 2, #08-22, SINGAPORE 408734
Model information
- Model Name(s)
- Corridor4DM Personal
- Model Identifier(s)
- Corridor4DM
About this record
Access comprehensive regulatory information for INVIA Corridor4DM Personal in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500391 and owned by INVIA, LLC.. The device was registered on February 18, 2016.
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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