Modality
28 source-backed listings mapped to this modality. Use each profile to verify FDA file number, workflow fit, integration, deployment, and unknown fields.
OrthoGrid Systems, Inc.
OrthoGrid Hip AI 4.0 analyzes two-dimensional C-arm fluoroscopic images to assist positioning of hip-replacement components during direct-anterior total hip arthroplasty.
Canon, Inc.
Canon Intelligent NR is a noise-reduction function for fluoroscopic images acquired on compatible Canon radiography and fluoroscopy systems.
Shimadzu Corporation
Trinias is an interventional fluoroscopic X-ray system for diagnostic and interventional angiography, including cardiac, neurovascular, abdominal, peripheral, rotational,...
Philips Medical Systems Nederland B.V.
EchoNavigator R5.0 supports an interventionalist or surgeon during cardiovascular treatment by combining live X-ray and live echocardiographic information.
Canon Medical Systems Corporation
Alphenix and INFX-8000V/B,S V9.6 with aEvolve FOV Extension are digital radiography and fluoroscopy systems for diagnostic and interventional angiography, with labeled real-time...
Depuy Ireland UC
VELYS Hip Navigation analyzes intraoperative X-ray or fluoroscopy for total hip arthroplasty with surgeon-confirmed landmark suggestions and measurements of cup orientation, leg...
Cara Medical, Ltd.
CARA assists adult structural-heart and conduction-system procedure planning by segmenting preprocedural CT, visualizing cardiac chambers and conduction landmarks, and overlaying...
Ge Hualun Medical Systems Co., Ltd.
OEC One CFD provides fluoroscopic and digital-spot images for adult and pediatric diagnostic, interventional, surgical, orthopedic, gastrointestinal, urologic, neurologic,...
Canon Medical Systems Corporation
Alphenix V9.6 with aEvolve Imaging is a digital radiography and fluoroscopy system for diagnostic and interventional angiography of the labeled vessels, with AI Denoising and MFP...
Metamorphosis GmbH
AIAS Cephalon assists qualified healthcare professionals during adult proximal femur fracture surgery by measuring and positioning implant components relative to bone structures...
Angiowave Imaging, Inc.
AngioWaveNet aids qualified physicians in analyzing and interpreting X-ray coronary angiographic cine images in adults by enhancing visibility of blood vessels, vascular...
Siemens Medical Solutions
LUMINOS Q.namix T and LUMINOS Q.namix R are multifunctional radiography and fluoroscopy systems for routine radiography and fluoroscopic examinations including gastrointestinal,...
Caranx Medical
TAVIPILOT detects, tracks, and marks the non-coronary cusp and prosthetic valve on live fluoroscopy during specified adult femoral TAVR or TAVI procedures under physician control.
Shanghai United Imaging Healthcare Co.,Ltd.
uAngio AVIVA CX provides image guidance for diagnostic, interventional, and surgical procedures, including cardiac, neuro, vascular, nonvascular, rotational angiography, and...
QFR Solutions bv
FDA product code QHA identifies this device class as X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device. X-ray angiographic imaging based coronary...
GE Medical Systems SCS
3DXR reconstructs cone-beam CT from interventional X-ray acquisitions and uses CleaRecon DL to reduce streak artifacts for display in the advanced workstation workflow.
Omega Medical Imaging, LLC
Soteria E-View supports radiographic and fluoroscopic applications, including general and pediatric diagnostic imaging and gastrointestinal or interventional X-ray procedures,...
Canon Medical Systems Corporation
FDA product code JAA identifies this device class as System, X-Ray, Fluoroscopic, Image-Intensified. Consult the linked FDA record for the exact authorized indications for use.
Medipixel, 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 SCS
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.
Therenva SAS
EndoNaut fuses planning images with live fluoroscopy and provides computerized navigation support for fluoroscopy-guided aneurysm repair, embolization, and peripheral-artery...
Cydar Ltd.
Cydar EV and Cydar EV Maps support the labeled endovascular workflow by processing and displaying patient-specific vascular imaging and maps for trained procedural professionals...
Omega Medical Imaging, LLC
Soteria.AI provides the cleared image-processing support described in K212336 for supported fluoroscopic studies; outputs are reviewed by trained professionals within the labeled...
GE Medical Systems SCS
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.
Therenva SAS
EndoNaut overlays preoperative three-dimensional vascular anatomy on live fluoroscopy and supports semi-automatic registration and motion detection for selected aneurysm,...
Omega Medical Imaging, LLC
CS-series-FP radiographic and fluoroscopic systems support cardiac, vascular, general, and interventional procedures; FluoroShield provides secondary region-of-interest...
Agfa HealthCare N.V.
DR 800 with MUSICA Dynamic supports digital radiography and dynamic-fluoroscopy examinations including routine radiography, positioning, gastrointestinal, urogenital,...
Cydar Ltd.
Cydar EV provides image guidance by overlaying preoperative 3D vessel anatomy from a previously acquired contrast-enhanced diagnostic CT scan onto live fluoroscopic images to...