FDA UDI
In Commercial Distribution
🇺🇸 United States
Brainlab Elements Image Fusion
DI: 04056481143992
·
Model: 4.5
·
Brainlab AG
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Brainlab Elements Image Fusion
- Primary DI
- 04056481143992
- Version / Model
- 4.5
- Company Name
- Brainlab AG
- Labeler DUNS
- 314482980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-20
- Public Version
- 1
- Public Version Date
- 2023-07-28
- Public Version Status
- New
- Public Device Record Key
- dc09b243-1185-4035-8281-8b78366c9d27
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 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | 892.1750 | 2 |
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40885 | Stereotactic system application software | An application software program intended to facilitate stereotactic treatment procedures (surgery or radiosurgery) by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, real-time surgical navigation and/or patient/procedure data management, image processing/transfer, and quality assurance. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04056481143992 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223106 | 000 |