FDA UDI
In Commercial Distribution
🇺🇸 United States
inHEART Models Explorer
DI: 03770019599006
·
Model: v2.2.1
·
INHEART
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- inHEART Models Explorer
- Primary DI
- 03770019599006
- Version / Model
- v2.2.1
- Company Name
- INHEART
- Labeler DUNS
- 269837780
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-06
- Public Version
- 2
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- c65c92bc-7724-480c-99b8-d9325c5a62d0
Device Description
inHEART Models Explorer is a web-based visualization software for display, review, annotation and export of digital 3D models segmented from medical images including cardiac images (CT and/or MR). It is intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians), as well as by inHEART trained staffs. inHEART Models Explorer is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians). 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
- Yes
- 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 |
|---|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | Radiology | 892.2020 | 1 |
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 | 03770019599006 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]