brAIn Shoulder Positioning
- Primary DI
- 03770026095034
- Brand
- brAIn Shoulder Positioning
- Company
- AVATAR MEDICAL
- Model
- BSP001
- Device description
- The brAIn Shoulder Positioning (BSP) software is a cloud-based application intended for shoulder surgeons. It is used to plan anatomic and reverse total shoulder replacement surgeries using FX Shoulder Solutions implants. The software is accessible via a web-based interface, where the user is prompted to upload their patient's information accompanied with their shoulder CT-scan (DICOM series) in a dedicated interface. The software automatically segments (using machine learning) and performs measurements on the scapula and humerus anatomy contained in the DICOM series. These segmentations are used for planning, which includes a live 3D viewer that allows for soft tissue visualization. Implants for the glenoid and humerus are positioned using this same 3D interface through a dedicated 3D manipulation gizmo. The changes in shoulder anatomy resultant from the implants are relayed in a post-position interface that displays information related to distalization and lateralization. The software outputs a planning mul
- Published
- 2025-04-14
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| QIH | Automated Radiological Image Processing Software |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QIH | Automated Radiological Image Processing Software | Radiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 03770026095034 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 03770026095034 | 03770026095034 | 3770026095034 |
GMDN Terms
| Term | Definition |
|---|
| Orthopaedic/craniofacial implantation planning software | A software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant. |
Regulatory Flags
- DUNS number
- 274654951
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
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|---|
| 03770026095041 | Avatar Medical Vision | AMV | | 2025-01-01 |
| 03770026095003 | Avatar Medical Software V1 | AMS V1 | | 2023-12-13 |
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