FDA-cleared K260077

OrthoGrid Hip AI® 4.0

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.

Modality
Fluoroscopy/Angiography
Anatomy
Hip
Decision
2026-05-29
FDA-cleared K252503

Intelligent NR

Canon, Inc.

Canon Intelligent NR is a noise-reduction function for fluoroscopic images acquired on compatible Canon radiography and fluoroscopy systems.

Modality
Fluoroscopy/Angiography
Anatomy
Whole body; diagnostic and interventional anatomy
Decision
2026-04-30
FDA-cleared K253269

OEC One CFD

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,...

Modality
Fluoroscopy/Angiography
Anatomy
Orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical-care, and emergency anatomy
Decision
2025-11-26
FDA-cleared K243446

3DXR

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.

Modality
Fluoroscopy/Angiography
Anatomy
Multi-region
Decision
2025-02-25
FDA-cleared K242488

Soteria E-View

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,...

Modality
Fluoroscopy/Angiography
Anatomy
Gastrointestinal, general, pediatric, and interventional X-ray anatomy
Decision
2025-01-06
FDA-cleared K222070

EndoNaut

Therenva SAS

EndoNaut fuses planning images with live fluoroscopy and provides computerized navigation support for fluoroscopy-guided aneurysm repair, embolization, and peripheral-artery...

Modality
Fluoroscopy/Angiography
Anatomy
Multi-region
Decision
2022-10-25
FDA-cleared K212442

Cydar EV (Series B) and Cydar EV Maps

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...

Modality
Fluoroscopy/Angiography
Anatomy
Peripheral vascular and endovascular anatomy
Decision
2021-12-03
FDA-cleared K212336

Soteria.AI

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...

Modality
Fluoroscopy/Angiography
Anatomy
Fluoroscopic procedure anatomy represented in supported X-ray studies
Decision
2021-11-17