brAIn Shoulder Positioning

Primary DI
03770026095034
Brand
brAIn Shoulder Positioning
Company
AVATAR MEDICAL
Model
BSP001
Device description
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
Published
2025-04-14
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

Related Records

Product Codes

CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications

CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03770026095034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03770026095034037700260950343770026095034

GMDN Terms

TermDefinition
Orthopaedic/craniofacial implantation planning softwareA 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.

Sterilization Methods

Method

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 DIBrandModelCatalogPublished
03770026095041Avatar Medical VisionAMV2025-01-01
03770026095003Avatar Medical Software V1AMS V12023-12-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04068151020076syngo DynamicsSiemens Healthcare GmbHQIH2026-03-19
09369900000857SalixARTRYA USA INC.QIH2026-02-17
09369998252183SalixARTRYA USA INC.QIH2026-02-17
08720892617637LumiNE USAugmedIT B.V.QIH2026-02-13
00860009223660Neosoma Brain MetsNeosoma, Inc.QIH2026-02-10
00860010268087Segmentron ViewerDGNCT LLCQIH2026-01-29
06429810209054SMART PCFDDisior OyQIH2026-01-27
05070003179800CDM InsightsOXFORD BRAIN DIAGNOSTICS LTDQIH2026-01-26
CARDIOVASCCALCT1TeraRecon Cardiovascular.Calcification.CT Terarecon Inc.QIH2026-01-23
08809944936220HERA Z30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-01-20
00810056991357aprevoCarlsmed, Inc.QIH2026-01-15
00198953109434LOGIQGE Ultrasound Korea Ltd.QIH2026-01-14
00884838129771LVivo View SelectionPhilips Ultrasound LLCQIH2025-12-18
00860003567944Second Opinion 3DPearl Inc.QIH2025-12-12
00860005586394Overjet CBCT AssistOverjet, Inc.QIH2025-12-12
03663999000436AutoDensityEOS IMAGINGQIH2025-12-09
04260729622006VELYS Traumametamorphosis GmbHQIH2025-12-01
00841517112424Sonosite PXFUJIFILM SONOSITE, INC.QIH2025-11-24
00860011384809ConstellationQ Bio, Inc.QIH2025-10-17
05430002070124FEopsFEopsQIH2025-09-25
E2472110100003A20VistaSoftDÜRR DENTAL SEQIH2025-09-22
04262352353517DS Core DiagnosisZetta25 AGQIH2025-09-05
00884838129276Ultrasound WorkspacePhilips Ultrasound LLCQIH2025-08-29
04068151009460syngo.MI GeneralSIEMENS MEDICAL SOLUTIONS USA, INC.QIH2025-08-13
04068151009453syngo.MM OncologySIEMENS MEDICAL SOLUTIONS USA, INC.QIH2025-08-11
06971576834204uOmnispaceShanghai United Imaging Healthcare Co., Ltd.QIH2025-08-02
06971576834228uOmnispaceShanghai United Imaging Healthcare Co., Ltd.QIH2025-08-02
06971576834259uOmnispaceShanghai United Imaging Healthcare Co., Ltd.QIH2025-08-02
03663999000412VEA AlignEOS IMAGINGQIH2025-08-01
00198953030233CaptionGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcQIH2025-07-28