Interventional Fluoroscopic X-Ray System
FDA product code OWB · 299 cleared devices
Class 2
Radiology
- Regulation
- 21 CFR 892.1650
- Review panel
- RA
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1991-08-28 – 2026-08-21
Interventional fluoroscopy
OWB
2026-08-21
OWB
2026-08-19
EXTRON 3;EXTRON 6
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OWB
2026-08-07
Zenition 30
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2026-07-31
Shield System (Siemens 30x40)
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OWB
2026-07-10
SmartCT (R3.0 (L10))
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OWB
2026-05-22
C-beam
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OWB
2026-04-30
Intelligent NR
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OWB
2026-04-24
ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno
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OWB
2026-04-23
ARTIS genio floor; ARTIS icono.explore floor
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OWB
2026-04-02
BELLIGER ACE
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OWB
2026-03-24
Trinias
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OWB
2026-03-10
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
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OWB
2026-02-20
CARA System
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OWB
2026-02-11
ArmSure Fluoroscopic Positioning System
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2026-01-16
Azurion R3.1
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2025-12-22
MC2 Portable X-ray System
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2025-12-16
SKAN C PULSAR
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2025-12-09
Allia Moveo
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2025-11-04
Cios Select
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OWB
2025-10-24
Azurion R3.1
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OWB
2025-10-10
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
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OWB
2025-07-29
Cios Spin
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OWB
2025-07-22
Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
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OWB
2025-07-14
LUMINOS Q.namix T; LUMINOS Q.namix R
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OWB
2025-07-09
Cios Alpha; Cios Flow
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OWB
2025-07-07
TAVIPILOT
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OWB
2025-06-10
EXTRON 3; EXTRON 5; EXTRON 7
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OWB
2025-05-19
Diagnostic X-ray System
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OWB
2025-05-16
MasteRad MiniX Mobile Digital Imaging System (Mini-X)
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2025-04-30
Persona C HR
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OWB
2025-04-28
uAngio AVIVA CX
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OWB
2025-03-28
ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)
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2025-03-17
Ziehm Solo FD
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OWB
2025-03-13
Ziehm Vision FD
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OWB
2025-02-25
3DXR
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OWB
2025-01-21
Ziehm Vision RFD 3D
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OWB
2025-01-15
Ziehm Vision RFD
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OWB
2024-12-06
MC2 Portable X-ray System
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OWB
2024-10-22
ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)
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OWB
2024-08-30
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5
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OWB
2024-06-21
O-arm O2 Imaging System
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OWB
2024-06-21
See Factor CT3™
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OWB
2024-05-22
Zenition 90
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OWB
2024-05-22
IntraOp Alignment System
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OWB
2024-04-26
DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl
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OWB
2024-03-15
CIARTIC Move (VB10)
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OWB
2024-02-16
Zenition 30
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OWB
2024-02-05
Ziehm Vision RFD
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OWB
2024-01-30
Ziehm Vision FD
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OWB
2024-01-26
Ziehm Solo FD
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OWB
2023-12-15
Ziehm Vision FD
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OWB
2023-12-15
ARTIS pheno (VE30A)
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OWB
2023-12-14
ARTIS icono (VE30A)
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OWB
2023-12-12
Ziehm Solo FD
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OWB
2023-11-20
Ziehm Vision RFD
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OWB
2023-11-16
XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
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OWB
2023-10-11
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
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OWB
2023-08-17
EXTRON 5; EXTRON 7
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OWB
2023-07-20
Oscar 15 & Oscar 15i
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OWB
2023-07-10
Ziehm Vision RFD 3D
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OWB
2023-06-20
F3
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OWB
2023-06-01
ANT-X System
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OWB
2022-12-28
nView s1 with nav option
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OWB
2022-12-07
Cios Select (VA21) Flat Panel
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OWB
2022-12-06
Cios Select (VA21) Image Intensifier
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OWB
2022-12-01
Bolt Navigation System
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OWB
2022-11-17
Multitom Rax
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OWB
2022-10-25
EndoNaut
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OWB
2022-10-06
Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
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OWB
2022-09-30
Shield System
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OWB
2022-09-27
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3
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OWB
2022-07-28
Trinias
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OWB
2022-07-28
TRON
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OWB
2022-07-19
ARTIS icono (Ceiling Configuration)
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OWB
2022-06-29
ARTIS icono (VE21) System
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OWB
2022-06-29
ARTIS pheno (VE21) System
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OWB
2022-06-07
D²RS and D²RS 9090
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OWB
2022-05-03
Cardiovascular Angiography System
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OWB
2022-04-15
SURGIVISIO Device
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OWB
2022-03-30
Shield System
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OWB
2022-03-18
SURGIVISIO Device
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OWB
2022-03-09
ZEN-2090 Turbo
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OWB
2022-02-18
Multitom Rax with True2scale Body Scan Option
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OWB
2021-12-23
D²RS and D²RS 9090
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OWB
2021-12-03
Cydar EV (Series B) and Cydar EV Maps
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OWB
2021-11-24
ControlRad Select Model Z
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OWB
2021-11-17
Soteria.AI
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OWB
2021-11-08
FDR Cross (DR-XD 3000)
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OWB
2021-11-05
VFSS Pro Mobile Digital Imaging System
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OWB
2021-10-29
nView s1 with nav option
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OWB
2021-10-01
Zenition 70
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OWB
2021-09-24
Virtual C DRF-NEO Digital Imaging System
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OWB
2021-08-31
EndoNaut
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OWB
2021-08-13
ARCO FP-S
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OWB
2021-08-12
Excelsius3D
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OWB
2021-07-01
ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9
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OWB
2021-06-24
Virtual C DRF Digital Imaging System
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OWB
2021-04-28
Trinias
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OWB
2021-04-12
Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
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OWB
2021-04-05
StentBoost Mobile
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