Use case
A buyer-oriented shortlist for msk and bone. Confirm exact intended use and local validation needs before any pilot or procurement decision.
Agada Medical, Ltd.
Auto-Seg and Spine Auto-Seg accept spine and pelvis CT images and provide three-dimensional segmentation and labels to support spine-surgery planning and assessment by spine...
Mighty Oak Medical
Acorn 3D Software and Acorn 3DP Model process CT, synthetic CT, and CT angiography for segmentation, visualization, measurement, treatment planning, and three-dimensional...
Alpha Intelligence Manifolds, 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...
Medicrea International S.A.S. (Medtronic)
UNiD Spine Analyzer SW3002 v5.1.0 enables healthcare professionals to view and measure images and plan orthopedic spine surgeries, including preoperative and postoperative...
AZmed
Rayvolve supports clinicians by identifying suspected fractures, joint effusions, and dislocations on labeled radiographic views; it does not replace clinician interpretation.
Smart Soft Healthcare AD
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Ge Healthcare Japan Corporation
True Definition DL is a deep-learning CT reconstruction function that enhances high-contrast spatial resolution for bone and lung imaging on compatible CT systems.
Esaote, S.p.A.
Magnifico Open is a general-purpose MRI system that acquires, displays, and analyzes MR images and real-time imaging for the labeled body regions and open-MRI applications.
Aidoc Medical, Ltd.
BriefCase-Triage CARE Multi-Triage CT analyzes contrast and non-contrast chest, abdomen, or chest/abdomen CT in adults or transitional adolescents aged 18 and older to flag...
Ge Medical Systems, LLC
SIGNA Bolt is a whole-body MRI system for high-resolution diagnostic imaging of the labeled body regions, with supported AI-assisted reconstruction, positioning, and protocol...
Ge Medical Systems, LLC
SIGNA Sprint Select is a whole-body MRI system for diagnostic imaging of the labeled body regions, with supported AI-assisted reconstruction, positioning, and protocol functions.
Qure.Ai Technologies
qXR-Detect is an adult chest-radiograph concurrent reading aid that identifies, highlights and categorizes suspicious regions of interest across lung, pleura,...
HeartLung Corporation
AI-CVD provides automated quantitative CT-derived anatomical and density measurements for clinician review, including calcium scores, cardiac and vascular measurements, lung and...
Mighty Oak Medical
Acorn 3D Software provides modular image processing, visualization, segmentation, measurement, treatment planning, and three-dimensional-printing support; Acorn Trajectory...
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...
Mighty Oak Medical
Acorn 3D Software with Acorn 3DP Model provides modular image processing, visualization, segmentation, measurements, treatment planning, and three-dimensional models, including...
Siemens Healthineers AG
Syngo Carbon Clinicals VA41 provides advanced visualization and analysis for clinical images, including OrthoMatic Spine whole-spine curve-angle measurements and TimeLens...
Metamorphosis GmbH
AIAS Cephalon assists qualified healthcare professionals during adult proximal femur fracture surgery by measuring and positioning implant components relative to bone structures...
Shanghai United Imaging Healthcare Co., Ltd.
uDR Aurora CX acquires two-dimensional X-ray images of the labeled skull, spine, chest, abdomen, extremities, limbs, and trunk for review by qualified healthcare professionals; it...
GE Medical Systems, LLC
SIGNA Sprint is a 1.5T whole-body MRI system for diagnostic imaging of the labeled head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, vessels, and...
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...
GE Hualun Medical Systems Co., Ltd
Definium Tempo Select acquires, displays, and manages digital radiographic images of the skull, spine, chest, abdomen, extremities, and other labeled body parts for routine...
EOS imaging
VEA Align is cloud-based software for orthopedic applications in adult and pediatric populations using two-dimensional X-ray images from EOS imaging systems to display interactive...
Medicrea International S.A.S. (Medtronic)
UNiD Spine Analyzer assists healthcare professionals in viewing and measuring images and planning orthopedic spine surgery, including preoperative and postoperative measurements,...
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...
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.CT provides healthcare institutions with tools to view, manipulate, evaluate, and analyze medical CT images, including colon, lung, vessel, brain, cardiac, liver, rib,...
Pearl Inc.
Second Opinion BLE identifies and displays bone-level measurements in bitewing and periapical radiographs for dental health professionals reviewing permanent teeth in patients age...
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.
Vent Creativity
Vent Creativity Knee v1.0 (Hermes) assists healthcare professionals in transferring CT imaging into bone segmentation and preoperative orthopedic planning outputs, including...
GE Medical Systems, LLC
SIGNA Prime Elite is a whole-body MR system that produces cross-sectional, spectroscopic, parametric, and dynamic images of the labeled body regions for trained physician...
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
BoneMetrics is fully automated software that assists trained radiology professionals with Cobb-angle measurement on frontal spine radiographs in patients aged four years or older...
Milvue
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 Israel, Functional Imaging
Clarify DL is a deep-learning reconstruction function intended to reduce noise and improve image quality of nuclear-medicine bone SPECT scintigraphy for all ages on the supported...
Ortho AI LLC
Ortho AI measures lengths, angles, and implant position relative to bone on radiographic images for total hip arthroplasty, total knee arthroplasty, and lumbar-spine fusion...
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....
GE Medical Systems, LLC
SIGNA MAGNUS is a head-only MR system intended for diagnostic imaging of structures and functions of the head, neck, temporomandibular joint, and limited cervical spine in...
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...
Smart Soft Healthcare
CoLumbo version 3 is an image post-processing and measurement tool that provides quantitative measurements of the lumbar spine from previously acquired lumbar-spine MR images.
GE Medical Systems Israel, Functional Imaging
Omni Legend is a PET/CT system for attenuation-corrected PET with positron-emitting radiopharmaceuticals across whole-body, head, heart, brain, lung, breast, bone,...
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...
Subtle Medical, Inc.
SubtleSYNTH is a software medical device consisting of a machine-learning algorithm that synthesizes a SynthSTIR contrast image from T1-weighted and T2-weighted spine MR images.
EOS imaging
VEA Align uses 2D X-ray images acquired in EOS imaging systems to display interactive landmarks and support global-alignment assessment, angle and length measurements, and...
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....
Siemens Medical Solutions
YSIO X.pree is a digital X-ray system designed to visualize anatomical structures and generate X-ray images from the whole body, including the skull, chest, abdomen, spine, limbs,...
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.CT is software for viewing, manipulating, evaluating, and analyzing medical images within healthcare institutions. The FDA indication lists colon visualization, dental...
16 Bit Inc
Rho analyzes standard frontal radiographs opportunistically to identify patients aged 50 years and older who may have low bone mineral density and to prompt clinical bone-health...
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.
GE Healthcare (Tianjin) Company Limited
The SIGNA Champion is a whole-body magnetic resonance scanner indicated to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, spectra,...
EOS imaging
VEA Align is cloud-based orthopedic software that uses 2D frontal and lateral X-ray images acquired in EOS imaging systems to display interactive landmarks and support...
Disior Ltd
Bonelogic 2.2 assists orthopedic healthcare professionals with diagnosis and surgical planning by semi-automatically segmenting bony structures from CT and producing foot and...
Adra Corporation
Adravision Perio is semi-automated radiological image-processing software intended to aid dental professionals in measuring mesial and distal bone levels associated with each...
Carlsmed, Inc.
aprevo Digital Segmentation is software for trained, medically knowledgeable design personnel to perform digital image segmentation of the spine, primarily lumbar anatomy; it...
Momentum Health Inc.
The Momentum Spine optical-contour-sensing mobile application quantifies asymmetries and assesses body angles and curve progression related to postural asymmetries, including...
Ewoosoft Co., Ltd
Ez3D-i/E3 provides dental and maxillofacial DICOM viewing, three-dimensional visualization, multiplanar reconstruction, two-dimensional analysis, implant simulation, canal...
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.
FUJIFILM Healthcare Corporation
The ECHELON Synergy MRI system is a 1.5T MR imaging device that provides non-ionizing physiological and clinical information and produces transverse, coronal, sagittal, oblique,...
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....
MEDICALIP Co., Ltd
DeepCatch analyzes whole-body CT images to segment skin, bone, muscle, visceral fat, subcutaneous fat, internal organs, and central nervous system structures, then calculates...
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...
Nobel Biocare AB
DTX Studio Clinic 3.0 analyzes intraoral bitewing and periapical radiographs of permanent teeth in patients aged 15 years and older to identify and localize caries, calculus,...
Synapsica
RadioLens v1.0 is a medical diagnostic application for displaying, processing, storing, and transferring DICOM data other than mammography, with filtering, digital manipulation,...
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...
GE Healthcare
The Xeleris V Processing and Review System displays, processes, archives, prints, reports, and networks planar, SPECT, and PET nuclear-medicine data, with optional applications...
MRIguidance B.V.
BoneMRI is image-processing software that enhances visualization of bone structures in MRI images relative to surrounding soft tissue.
GE Healthcare (Tianjin) Company Limited
SIGNA Victor is a whole-body magnetic-resonance scanner for high-resolution imaging, high signal-to-noise ratio, and short scan times. It is indicated to produce axial, sagittal,...
MRlguidance B.V.
BoneMRI enhances bone contrast in dedicated MRI examinations of the pelvic sacrum, hip bones, femoral heads, and lumbar spine from L3 through S1; it is not intended to diagnose or...
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
The Automated Bone Mineral Density Software Module measures bone mineral density from existing CT by averaging Hounsfield units in trabecular vertebral bone and can calculate age-...
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
BoneView is a concurrent reading aid that analyzes radiographs and highlights areas suspicious for fractures in adults during physician interpretation.
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 enhances bone contrast in pelvic MRI examinations of the sacrum, hip bones, and femoral heads; it is not intended to diagnose or monitor primary or metastatic tumors and...
Canon Medical Systems Corporation
Aquilion Exceed LB is a CT system for cross-sectional imaging of the labeled body regions and examinations described in K211828, with professional review of acquired and...
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...
Subtle Medical, Inc.
SubtleMR is MRI image-processing software for reducing noise in supported head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI or increasing sharpness for...
Aidoc Medical, Ltd.
BriefCase analyzes supported noncontrast head CT, head CTA, noncontrast cervical-spine CT, and CTPA examinations to triage suspected intracranial hemorrhage, large-vessel...
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.