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
Use case
Fluoroscopy/Angiography workflow radiology AI tools
A buyer-oriented shortlist for fluoroscopy/angiography workflow. Confirm exact intended use and local validation needs before any pilot or procurement decision.
FDA-cleared K180589
DR 800 with MUSICA Dynamic
Agfa HealthCare N.V.
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2018-04-05
FDA-cleared K191713
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)
Omega Medical Imaging, LLC
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2019-10-04
FDA-cleared K212383
EndoNaut
Therenva SAS
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2021-08-31
FDA-cleared K212336
Soteria.AI
Omega Medical Imaging, LLC
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2021-11-17
FDA-cleared K212442
Cydar EV (Series B) and Cydar EV Maps
Cydar Ltd.
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2021-12-03
FDA-cleared K222070
EndoNaut
Therenva SAS
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2022-10-25
FDA-cleared K232526
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
Canon Medical Systems Corporation
Image analysis/processing for Vascular using Fluoroscopy/Angiography.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- Vascular
- Decision
- 2023-09-12
FDA-cleared K240465
O-arm O2 Imaging System
Medtronic Navigation, Inc
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2024-06-21
FDA-cleared K242488
Soteria E-View
Omega Medical Imaging, LLC
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2025-01-06
FDA-cleared K243446
3DXR
GE Medical Systems SCS
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2025-02-25
FDA-cleared K243376
uAngio AVIVA CX
Shanghai United Imaging Healthcare Co.,Ltd.
Image analysis/processing for Vascular using Fluoroscopy/Angiography.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- Vascular
- Decision
- 2025-04-28
FDA-cleared K243884
TAVIPILOT
Caranx Medical
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2025-07-07
FDA-cleared K250660
LUMINOS Q.namix T; LUMINOS Q.namix R
Siemens Medical Solutions
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2025-07-14
FDA-cleared K251602
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2025-10-10