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 | 809 Cuesta Dr Ste B Pmb 216 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 software is a cloud-based application intended for shoulder surgeons. The software does not perform surgical planning but provides tools to assist the surgeon with planning primary 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 shoulder CT-scan (DICOM series) accompanied with their information 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 serve as a foundation for the surgeon’s manual planning, which is performed using an interactive 3D viewer that allows for soft tissue visualization. The surgeon positions the glenoid and humerus implants manually within this same 3D interface using a dedicated manipulation panel. 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 multimodal summary that includes textual information (patient information, pre- and post-op measurements) and visual information (screen captures of the shoulder pre- and post-implantation).
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