FDA UDI
Not in Commercial Distribution
🇺🇸 United States
inHEART MODELS Explorer
DI: 03770019599099
·
Model: v2.8.0
·
INHEART
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- inHEART MODELS Explorer
- Primary DI
- 03770019599099
- Version / Model
- v2.8.0
- Company Name
- INHEART
- Labeler DUNS
- 269837780
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-08
- Public Version
- 2
- Public Version Date
- 2025-07-16
- Public Version Status
- Update
- Public Device Record Key
- 80a092e5-999b-4f34-b37f-76dea7bea0cc
- Distribution End Date
- 2024-09-18
Device Description
inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART MODELS Shaper. inHEART MODELS Explorer is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions.
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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41670 | Radiological PACS software | An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03770019599099 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231683 | 000 |