Avatar Medical Vision
- Primary DI
- 03770026095041
- Brand
- Avatar Medical Vision
- Company
- AVATAR MEDICAL
- Model
- AMV
- Device description
- Avatar Medical Vision is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. Avatar Medical Vision is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
- Published
- 2025-01-01
- 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 |
|---|
| LLZ | System, Image Processing, Radiological |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LLZ | System, Image Processing, Radiological | Radiology | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K222035 | 000 | Avatar Medical Software V1 | Avatar Medical | 2023-05-24 | LLZ |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 03770026095041 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 03770026095041 | 03770026095041 | 3770026095041 |
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
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 03770026095034 | brAIn Shoulder Positioning | BSP001 | | 2025-04-14 |
| 03770026095003 | Avatar Medical Software V1 | AMS V1 | | 2023-12-13 |
Other Devices Sharing Product Codes