gudid
Primary ID: Cardiac.Chambers.MR01
TeraRecon Cardiac.Chambers.MR (UDI Cardiac.Chambers.MR01)
Manufactured by Terarecon Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for TeraRecon Cardiac.Chambers.MR - Primary ID Cardiac.Chambers.MR01
Device Regulatory Overview
The TeraRecon Cardiac.Chambers.MR (Model/Catalog Number: Cardiac.Chambers.MR01) 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
- Cardiac.Chambers.MR01
- Product Code / EMDN
- QIH
- Device Name
- This Software as a Medical Device provides a user with automatic contouring of delayed enhancement and ejection fractions studies. Ejection fraction studies are segmented in short axis views for verification and accuracy.
- 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 Cardiac.Chambers.MR?
The registered manufacturer of record for TeraRecon Cardiac.Chambers.MR is Terarecon Inc..
What is the Primary UDI-DI identifier for TeraRecon Cardiac.Chambers.MR?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Cardiac.Chambers.MR01.
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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