FDA-cleared K252099

Trinias

Shimadzu Corporation

FDA product code OWB identifies this device class as Interventional Fluoroscopic X-Ray System. Interventional fluoroscopy Consult the linked FDA record for the exact authorized...

Modality
Fluoroscopy/Angiography
Anatomy
N/A
Decision
2026-03-24
FDA-cleared K253614

EchoNavigator R5.0

Philips Medical Systems Nederland B.V.

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
2026-03-17
FDA-cleared K253269

OEC One CFD

Ge Hualun Medical Systems Co., Ltd.

FDA product code OXO identifies this device class as Image-Intensified Fluoroscopic X-Ray System, Mobile. Fluoroscopy of the human body. Consult the linked FDA record for the...

Modality
Fluoroscopy/Angiography
Anatomy
N/A
Decision
2025-11-26
FDA-cleared K250660

LUMINOS Q.namix T; LUMINOS Q.namix R

Siemens Medical Solutions

FDA product code OWB identifies this device class as Interventional Fluoroscopic X-Ray System. Interventional fluoroscopy Consult the linked FDA record for the exact authorized...

Modality
Fluoroscopy/Angiography
Anatomy
N/A
Decision
2025-07-14
FDA-cleared K243376

uAngio AVIVA CX

Shanghai United Imaging Healthcare Co.,Ltd.

FDA product code OWB identifies this device class as Interventional Fluoroscopic X-Ray System. Interventional fluoroscopy Consult the linked FDA record for the exact authorized...

Modality
Fluoroscopy/Angiography
Anatomy
Vascular
Decision
2025-04-28
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

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.

Modality
Fluoroscopy/Angiography
Anatomy
N/A
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

FDA product code OWB identifies this device class as Interventional Fluoroscopic X-Ray System. Interventional fluoroscopy Consult the linked FDA record for the exact authorized...

Modality
Fluoroscopy/Angiography
Anatomy
N/A
Decision
2022-10-25
FDA-cleared K212442

Cydar EV (Series B) and Cydar EV Maps

Cydar Ltd.

FDA product code OWB identifies this device class as Interventional Fluoroscopic X-Ray System. Interventional fluoroscopy Consult the linked FDA record for the exact authorized...

Modality
Fluoroscopy/Angiography
Anatomy
N/A
Decision
2021-12-03
FDA-cleared K212336

Soteria.AI

Omega Medical Imaging, LLC

FDA product code OWB identifies this device class as Interventional Fluoroscopic X-Ray System. Interventional fluoroscopy Consult the linked FDA record for the exact authorized...

Modality
Fluoroscopy/Angiography
Anatomy
N/A
Decision
2021-11-17
FDA-cleared K212383

EndoNaut

Therenva SAS

FDA product code OWB identifies this device class as Interventional Fluoroscopic X-Ray System. Interventional fluoroscopy Consult the linked FDA record for the exact authorized...

Modality
Fluoroscopy/Angiography
Anatomy
N/A
Decision
2021-08-31
FDA-cleared K180589

DR 800 with MUSICA Dynamic

Agfa HealthCare N.V.

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.

Modality
Fluoroscopy/Angiography
Anatomy
N/A
Decision
2018-04-05
FDA-cleared K160088

Cydar EV

Cydar Ltd.

Cydar EV provides augmented reality enhanced X-ray fluoroscopy images for use during X-ray guided surgery.

Modality
Fluoroscopy/Angiography
Anatomy
N/A
Decision
2016-07-07