Use case
A buyer-oriented shortlist for x-ray/radiography workflow. Confirm exact intended use and local validation needs before any pilot or procurement decision.
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....
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.
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...
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:...
Velmeni Inc.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
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:...
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.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
AZmed
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Gleamer SAS
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Pearl Inc.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
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...
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....
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.
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.
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....
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...
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....
Overjet, 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 QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Overjet Inc.
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:...
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....
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.
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...
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....
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.
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.
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.
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.
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.