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
2021-03-26
OWB
2021-03-05
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Digiscan FDX
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ARTIS pheno (VE2)
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2020-06-24
ControlRad Trace Model 9
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2020-05-29
CFP-3131, CFP-2222
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2020-05-01
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2020-04-24
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2020-04-16
ARTIS Icono
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2020-04-15
AS-10
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2020-04-03
FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System
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2020-03-05
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2020-01-17
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2019-12-20
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2019-12-19
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2019-11-20
Ziehm 8000
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2019-09-12
ARTIS icono
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2019-09-04
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2019-08-20
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2019-07-08
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2019-05-13
ControlRad Trace Model 8
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2019-04-12
SyncVision System
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2018-12-31
Zenition 50
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2018-12-06
Zenition 70
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2018-11-02
Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
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2018-10-30
Cios Spin
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2018-10-24
Cios Alpha
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2018-10-17
Alphenix, INFX-8000H/B, V8.0
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2018-09-28
Alphenix, INFX-8000F/B, V8.0
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2018-09-10
XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0
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2018-08-17
SmartPerfusion
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2018-08-17
OSCAR (OSCAR Prime, OSCAR Classic)
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2018-08-17
Cios Select
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2018-08-15
Artis zee/zeego & Artis Q/Q.zen
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2018-08-02
Azurion R2.0
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2018-08-02
Alphenix, INFX-8000C/B, V8.0
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OWB
2018-07-25
Alphenix, INFX-8000V/B, V8.0
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2018-07-19
Ultimax-i, DREX-UI80 (V1.60)
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2018-07-11
Intelli-C
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2018-04-02
Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
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OWB
2018-03-23
ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR
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OWB
2018-02-28
TrackX
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OWB
2018-02-09
OSCAR 15
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OWB
2018-02-09
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
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OWB
2018-02-05
ProxiDiagnost N90
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OWB
2017-12-29
Medtronic O-arm O2 Imaging System
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OWB
2017-12-14
Infinix-i, INFX-8000V, V7.0
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OWB
2017-11-22
Azurion series R1.2
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OWB
2017-11-16
LessRay System
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OWB
2017-11-09
OEC One
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OWB
2017-10-30
XIDF-AWS801, Angio Workstation, V7.0
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OWB
2017-10-24
Dynamic Coronary Roadmap 2.0
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OWB
2017-10-05
SyncVision System
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OWB
2017-09-21
EndoNaut
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OWB
2017-08-18
NuVasive LessRay with Enhanced Tracking
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OWB
2017-08-10
OEC Elite
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OWB
2017-07-21
Ultimax-i, DREX-UI80 V1.60
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OWB
2017-06-16
Infinix INFX-8000V, V6.40
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OWB
2017-06-07
StentBoost Live
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OWB
2017-06-02
Dynamic Coronary Roadmap
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OWB
2017-05-26
SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
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OWB
2017-05-24
AS-10, CXDI-401RF
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OWB
2017-05-19
OEC Elite
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OWB
2017-03-09
ARTIS pheno
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OWB
2017-01-26
Allura Xper R9
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OWB
2016-12-02
Allura Xper FD series and Allura Xper OR Table series
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OWB
2016-11-23
Allura Xper R9
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OWB
2016-10-17
Infinix, INFX-8000V, V6.35
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OWB
2016-10-14
ANYVIEW-500R Fluoroscopic Mobile X-Ray System
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OWB
2016-10-06
Ziehm Solo FD
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OWB
2016-09-05
SyncVision System
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OWB
2016-08-25
AneurysmFlow
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OWB
2016-08-10
CT TrueView
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OWB
2016-07-29
2D Quantitative Analysis
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OWB
2016-07-29
Allura Xper FD series and Allura Xper OR Table series
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OWB
2016-07-07
Cydar EV
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OWB
2016-03-07
Cios Fusion
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OWB
2016-02-10
Cios Select
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OWB
2016-01-15
INFX-8000C, V6.20
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OWB
2016-01-12
Cios Connect
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OWB
2016-01-12
INFX-8000V, V6.20
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OWB
2013-12-16
2D PERFUSION
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OWB
2013-12-12
SYNC-RX SYSTEM
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OWB
2013-11-29
LESSRAY
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OWB
2013-10-30
STENTBOOST REL. 4
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OWB
2013-09-06
XPERCT REL. 3
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OWB
2013-07-24
XPERGUIDE
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OWB
2013-06-28
ALLURACLARITY XPER FD SERIES X-RAY SYSTEM
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OWB
2013-05-16
ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21
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OWB
2013-03-21
ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1
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