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…

Registry build 21.09.26

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).

8manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Beijing (4), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code QIH
Manufacturer City Province Registered as Device types
Philips Ultrasound (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 5
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
GE Hangwei Medical Systems Co., Ltd. Beijing Beijing Specification developer 22
GE Healthcare (China) Co., Ltd. Beijing Beijing Specification developer 22
Shanghai United Imaging Healthcare Co., Ltd. Shanghai Shanghai Manufacturer 12
Beijing Infervision Healthcare Medical Technology Co., Ltd. Beijing Beijing Complaint-file establishment 4
Wuhan United Imaging Healthcare Co., Ltd. Wuhan Hubei Manufacturer 4
Keya Medical Technology Co., Ltd. Beijing Beijing Manufacturer 2

Record

Regulatory record for brAIn Shoulder Positioning
Listed by Avatar Medical, France
FDA product code QIH
Device type Automated Radiological Image Processing Software
Device class Class 2
Regulation 21 CFR 892.2050
Establishment Manufacturer
Record published 2025-04-14
Record revised 2025-11-28 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for brAIn Shoulder Positioning
Catalogue number Size Status
BSP001 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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syngo.MI General Siemens Medical Solutions USA, Inc. 3
Neosoma Dashboard Neosoma, Inc. 3
BriefCase-Quantification Aidoc Medical Ltd. 3
OrthoNext™ Platform System Software Orthofix SRL 3
MI View&GO Siemens Medical Solutions USA, Inc. 3
FEops Feops NV 3
AI-Rad Companion Brain MR Siemens Healthcare Limited 3

Showing 12 of 147. All products under Automated Radiological Image Processing Software

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K252665 2025-10-20

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer