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 K222036

MPXA-2000

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....

Modality
Fluoroscopy/Angiography
Anatomy
N/A
Decision
2023-03-22
FDA-cleared K223490

FlightPlan for Embolization

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.

Modality
Fluoroscopy/Angiography
Anatomy
N/A
Decision
2023-03-21
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