Avatar Medical Software V1
Avatar Medical
AVATAR MEDICAL
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3027645731 | 3027645731 | AVATAR MEDICAL | 1 | N | 2026-01-01 | 11 Rue de lourmel paris Ile-de-France FR 75015 |
| 3030088845 | 3030088845 | AVATAR MEDICAL USA Inc | 1 | Y | 2026-01-01 | 1049 El Monte Ave, Suite C #152 Mountain View CA US 94040 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 319210 | 1072583134 | K253950 | Avatar Medical Vision | LLZ | 2026-03-30 |
| 319210 | 1533910388 | K252665 | brAIn™ Shoulder Positioning | QIH | 2025-10-20 |
| 319210 | 1679444742 | K222035 | Avatar Medical Software V1 | LLZ | 2023-05-24 |
Product Codes Associated With Registrations
PMN
GUDID
brAIn Shoulder Positioning - 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
2025-04-14
Avatar Medical Vision - 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.
2025-01-01
Avatar Medical Software V1 - AVATAR MEDICAL Software V1 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 Software V1 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.
2023-12-13