Use case
A buyer-oriented shortlist for msk and bone. Confirm exact intended use and local validation needs before any pilot or procurement decision.
Eos Imaging
AutoDensity estimates L1-L4 spine bone-mineral density from EOSedge dual-energy AP radiographs for opportunistic orthopedic pre-surgical assessment; it is not a replacement for...
Naitive Technologies Ltd
FDA product code SAO identifies this device class as Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density. This device is software which opportunistically...
EOS imaging
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Medicrea International S.A.S. (Medtronic)
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
FUJIFILM Healthcare Americas Corporation
Synapse PACS version 7.5 provides primary processing and presentation of DICOM and supported non-DICOM images with measurement, segmentation, fusion, volume rendering, reporting,...
Rivanna Medical, Inc.
Accuro 3S is portable B-mode ultrasound with SpineNav-AI for lumbar-spine scouting and epidural-depth estimation during neuraxial-anesthesia and needle or catheter placement...
BunkerHill Health
FDA product code KGI identifies this device class as Densitometer, Bone. Consult the linked FDA record for the exact authorized indications for use.
ScanDiags AG
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Gleamer SAS
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Milvue
FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...
icometrix NV
FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...
Remedy Logic Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Verdure Imaging
FDA product code IYO identifies this device class as System, Imaging, Pulsed Echo, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Avicenna.AI
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
AZmed SAS
FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...
EOS imaging
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Medtronic Navigation, Inc
O-arm O2 4.3.0 provides mobile intraoperative two- and three-dimensional X-ray imaging of bony anatomy and metal objects, navigation support, 3D Long Scan, implant artifact...
Ever Fortune.AI Co., Ltd.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
16 Bit Inc
FDA product code SAO identifies this device class as Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density. This device is software which opportunistically...
MRIguidance B.V
BoneMRI is image-processing software that enhances visualization of pelvic and spinal bone structures in MRI images relative to surrounding soft tissue.
Disior Ltd
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Momentum Health Inc.
FDA product code LDK identifies this device class as Device, Sensing, Optical Contour. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems SCS
FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.
Medical Metrics, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
GE Medical Systems, LLC
FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...
GE Medical Systems, LLC
FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.
Gleamer
FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...
MRIguidance B.V.
BoneMRI is image-processing software that enhances visualization of bone structures in MRI images relative to surrounding soft tissue.
MRlguidance B.V.
BoneMRI is image-processing software that enhances visualization of bone structures in MRI images relative to surrounding soft tissue.
Siemens Medical Solutions USA, Inc.
FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.
Medical Metrics, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
3D-Side SA
Customize supports adult total ankle arthroplasty planning with CT segmentation, three-dimensional models, implant positioning and sizing, treatment-plan review, and...
HeartLung Corporation
FDA product code KGI identifies this device class as Densitometer, Bone. Consult the linked FDA record for the exact authorized indications for use.
AZmed SAS
FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...
3D-Side SA
Customize supports adult shoulder arthroplasty planning with CT segmentation, three-dimensional models, implant positioning and sizing, case management, and physician approval; it...
Gleamer
FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...
MEDICREA International, Inc.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
MRIguidance B.V
BoneMRI is image-processing software that enhances visualization of bone structures in MRI images relative to surrounding soft tissue.
Aidoc Medical, Ltd.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Imagen Technologies, Inc.
FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...
Siemens Medical Solutions USA, Inc.
FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.
EXINI Diagnostics AB
aBSI analyzes nuclear-medicine whole-body bone scans and SPECT to mark lesions and quantify skeletal disease burden as a fraction of total skeletal weight for trained...
GE Medical Systems SCS
FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.
Imagen Technologies, Inc.
FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...
Medicrea International
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
MEDICREA INTERNATIONAL
UNiD Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries.