AVATAR MEDICAL

Matched from indexed company URL: Avatar Medical

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30276457313027645731AVATAR MEDICAL1N2026-01-0111 Rue de lourmel paris Ile-de-France FR 75015
30300888453030088845AVATAR MEDICAL USA Inc1Y2026-01-011049 El Monte Ave, Suite C #152 Mountain View CA US 94040

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3192101072583134K253950Avatar Medical VisionLLZ2026-03-30
3192101533910388K252665brAIn™ Shoulder PositioningQIH2025-10-20
3192101679444742K222035Avatar Medical Software V1LLZ2023-05-24

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
LLZ22026-03-30
QIH12025-10-20

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

AVATAR MEDICAL

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.

AVATAR MEDICAL

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.

AVATAR MEDICAL

2023-12-13