FDA UDI
In Commercial Distribution
🇺🇸 United States
TeraRecon Cardiac.Chambers.MR
DI: CARDIACCHAMBERSMR1
·
Model: Cardiac.Chambers.MR01
·
Terarecon Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TeraRecon Cardiac.Chambers.MR
- Primary DI
- CARDIACCHAMBERSMR1
- Version / Model
- Cardiac.Chambers.MR01
- Catalog Number
- CARDIACCHAMBERSMR1
- Company Name
- Terarecon Inc.
- Labeler DUNS
- 021677872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-16
- Public Version
- 1
- Public Version Date
- 2024-12-24
- Public Version Status
- New
- Public Device Record Key
- c44deb86-3cb4-4088-a846-f09fb6875ce6
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57812 | Radiology DICOM image processing application software | A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | CARDIACCHAMBERSMR1 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241312 | 000 |