TeraRecon Cardiovascular.Calcification.CT (UDI Cardiovascular.Calcification.CT01)
Manufactured by Terarecon Inc.
Device Regulatory Overview
The TeraRecon Cardiovascular.Calcification.CT (Model/Catalog Number: Cardiovascular.Calcification.CT01) is a medical device manufactured by Terarecon Inc.. This product is indexed under FDA Product Code / Category Classification QIH within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Cardiovascular.Calcification.CT01
- Product Code / EMDN
- QIH
- Device Name
- TeraRecon Cardiovascular.Calcification.CT is intended to provide an automatic 3D segmentation of calcified plaques within the coronary arteries and outputs a mask for calcium scoring systems to use for calculations. The results of TeraRecon Cardiovascular.Calcification.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care.
- Database Sync Date
- 2026-08-09 09:06:20
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of TeraRecon Cardiovascular.Calcification.CT?
The registered manufacturer of record for TeraRecon Cardiovascular.Calcification.CT is Terarecon Inc..
What is the Primary UDI-DI identifier for TeraRecon Cardiovascular.Calcification.CT?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Cardiovascular.Calcification.CT01.
What classification code is assigned to this device?
This device is registered under product classification code QIH.
Similar Classification Devices (QIH)
Other Devices by Terarecon Inc.
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