Identity
- Trade Name
- TeraRecon Cardiac.Chambers.MR FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- 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. FDA UDI
- Model / Reference
- Cardiac.Chambers.MR01 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- CARDIACCHAMBERSMR1 FDA UDI
- Primary DI / UDI-DI
- CARDIACCHAMBERSMR1 FDA UDI
- 510(k) Number
- K241312 FDA UDI
- FDA Product Code
- QIH FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology DICOM image processing application software
TeraRecon Cardiac.Chambers.MR by Terarecon Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Terarecon Inc.
Sources (1)
- FDA UDI c44deb86-3cb4-4088-a846-f09fb6875ce6 35 fields · synced May 31, 2026