Modality
120 source-backed listings mapped to this modality. Use each profile to verify FDA file number, workflow fit, integration, deployment, and unknown fields.
Crescom 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....
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...
AZmed
Rayvolve supports clinicians by identifying suspected fractures, joint effusions, and dislocations on labeled radiographic views; it does not replace clinician interpretation.
Velmeni, Inc.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Ge Medical Systems, LLC
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Overjet, Inc.
Overjet Iris is a web-based dental PACS for storing, viewing, and supporting image-quality review of two-dimensional intraoral radiographs, panoramic images, and color photographs.
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,...
Crescom 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....
Nobel Biocare C/O Medicim NV
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Pearl, Inc.
Second Opinion Panoramic is an automated image-processing aid that identifies and marks regions of interest for caries, periapical radiolucency, and impacted third molars on...
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...
Bench7, Inc.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
VideaHealth Inc.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
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...
Velmeni Inc.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
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...
Siemens Medical Solutions
YSIO X.pree is a digital X-ray system for whole-body radiographic imaging, including skull, chest, abdomen, and extremities, to support diagnostic and therapeutic decisions.
Pearl Inc.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Audax d.o.o.
AudaxCeph Cephalogram Analysis Software assists specialized dental practices with storing and presenting patient cephalogram images and treatment planning through landmark...
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....
Cube Click, Inc.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
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...
Pearl, Inc.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Annalise-AI
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Pearl Inc.
Second Opinion PC assists dentists by detecting and displaying periapical radiolucencies with bounding polygons on dental radiographs of permanent teeth in patients age 12 and...
AZmed
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
AZmed
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Better Diagnostics AI Corp
Better Diagnostics Caries Assist is a concurrent-read computer-aided detection device that identifies and localizes carious lesions on bitewing and periapical radiographs of...
Gleamer SAS
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Ever Fortune.AI, Co., Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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...
Pearl Inc.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
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...
Vuno Inc.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Overjet Inc
Overjet Image Enhancement Assist provides optional image-quality enhancement for dental radiographs. The FDA material describes learning-based noise reduction for bitewing and...
Velmeni Inc.
VELMENI for DENTISTS is concurrent-read, computer-assisted detection software intended to assist dentists in the clinical detection of dental caries, fillings or restorations,...
Overjet, Inc
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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...
Disior Ltd
SMART Bun-Yo-Matic X-Ray analyzes foot and ankle X-rays to provide visualizations, measurements, and surgical-planning information for orthopaedic care.
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...
Philips Medical Systems DMC GmbH
Radiography 7300 C is a diagnostic radiography system for producing and processing projection X-ray images in the labeled clinical workflow; exact views, detectors, patient...
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,...
Milvue
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
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...
Overjet, Inc
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Overjet, Inc
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Orca Dental AI 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.
Envisionit DeepAI Ltd
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
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...
Qure.ai Technologies
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
VideaHealth, Inc.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Nobel Biocare AB
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.
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...
Bering Ltd
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Denti.AI Technology, Inc.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
DeepTek Medical Imaging Pvt Ltd
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Imagen Technologies, Inc
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Qure.ai Technologies
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Overjet, Inc
Overjet Periapical Radiolucency Assist is a concurrent-read aid for detecting periapical radiolucencies on periapical radiographs of permanent teeth in patients aged 12 years and...
Imagen Technologies, Inc
Lung-CAD is a concurrent-read computer-aided detection aid for identifying and marking regions of interstitial thickening on adult chest radiographs; it does not provide a...
Alpha Intelligence Manifolds, Inc.
DeepXray is a fully automated CR or DX radiographic image-processing device intended to aid trained medical professionals in measuring minimum joint-space width, assessing...
Qure.ai Technologies
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Imidex Inc.
VisiRad XR is a computer-aided detection device that identifies and marks regions of interest suspicious for lung nodules and masses measuring 6-60 mm on chest radiographs in...
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....
IB Lab GmbH
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...
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,...
Annalise-AI Pty Ltd
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Annalise-AI Pty Ltd
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Overjet, Inc.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Gleamer
FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...
VideaHealth, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Quanta Computer Inc.
QOCA image Smart CXR analyzes adult chest X-ray images and flags cases with suspected pneumothorax to support prioritization for radiologist review.
Overjet Inc.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Ever Fortune AI Co., Ltd.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
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....
Imagen Technologies, Inc
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Ever Fortune.AI Co., Ltd.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
VinBrain Joint Stock Company
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
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...
Overjet, Inc.
Overjet Caries Assist is a concurrent-read aid for detecting and segmenting caries on bitewing radiographs of permanent dentition in patients aged 18 years and older; it provides...
VideaHealth, Inc
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
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....
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...
Riverain Technologies, Inc.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Pearl Inc.
Second Opinion is a concurrent-reading aid for dental professionals reviewing bitewing and periapical radiographs of permanent teeth in patients aged 12 years and older.
Gleamer
BoneView is a concurrent reading aid that analyzes radiographs and highlights areas suspicious for fractures in adults during physician interpretation.
Annalise-AI
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
OXOS Medical, Inc.
Micro C Medical Imaging System M01 is a handheld or portable general-purpose X-ray system for qualified clinicians to obtain diagnostic static or serial radiographic exposures of...
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.
Qure.ai Technologies
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Zebra Medical Vision Ltd.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Lunit Inc.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
GE Medical Systems, LLC
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Canon Inc.
Intelligent NR is a radiographic image-processing function for supported X-ray studies in the exact K212269 workflow; processed images are reviewed by qualified professionals and...
Samsung Electronics Co.,Ltd.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Radiobotics ApS
Indications for Use statement. Please note that the 510(k) submission was not re-reviewed.
Imagen Technologies, Inc
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Overjet, 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.
Carestream Health, Inc.
Eclipse II with Smart Noise Cancellation digitally enhances radiographic images generated by supported X-ray devices for adult and pediatric use; the cleared function is for...
Zebra Medical Vision 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.
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...
RADLogics, Inc.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Behold.AI Technologies Limited
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
OrthoGrid Systems 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.
Zebra Medical Vision, Ltd.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
IB Lab GmbH
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.
GE Medical Systems, LLC.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Zebra Medical Vision 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.
YSIO MAX is a digital radiography system for whole-body skull, chest, abdomen, and extremity imaging in pediatric, adult, and bariatric patients, including supported emergency and...
RIVERAIN TECHNOLOGIES
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.
RIVERAIN MEDICAL GROUP,LLC
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.
RIVERAIN MEDICAL GROUP
RAPIDSCREEN RS-2000 is a PMA-authorized computer-aided detection device that identifies and marks regions of interest on digitized frontal chest radiographs associated with...
CARESTREAM DENTAL LLC
LOGICON Caries Detector is adjunct software for detecting caries extending into dentin on unrestored proximal surfaces of secondary dentition in supported digital intraoral...