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
2013-02-26
OWB
2013-01-02
GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS
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OWB
2012-12-10
CARDNAV
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OWB
2012-12-05
LESSRAY
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OWB
2012-08-16
OEC 9900 ELITE
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OWB
2012-06-07
FLAT PANEL DETECTOR
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OWB
2012-02-14
GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM
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OWB
2012-01-26
INFX-8000V WITH
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OWB
2011-11-22
SYNGO AORTIC VALVEGUIDE SOFTWARE
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OWB
2011-10-04
OEC(R) 9800, OEC(R) 9800 PLUS
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OWB
2011-08-10
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)
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OWB
2011-06-10
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)
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OWB
2011-03-29
ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM
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OWB
2011-03-17
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM
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OWB
2010-10-07
D2RF DIGITAL DYNAMIC REMOTE SYSTEM
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OWB
2010-09-07
INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
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OWB
2010-08-31
CS-SERIES-FP
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OWB
2010-08-09
ALLURA XPER OR TABLE SERIES
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OWB
2010-07-23
INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
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OWB
2010-03-16
I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
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OWB
2010-02-04
CANON, MODEL URS-50RF
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OWB
2009-12-23
ZIEHM SOLO
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OWB
2009-11-30
CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF
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OWB
2009-10-07
ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO
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OWB
2009-08-25
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
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OWB
2009-06-29
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121
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OWB
2009-05-15
ZIEHM VISION RFD
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OWB
2009-05-01
OEC 9900 ELITE
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OWB
2009-03-16
VERADIUS, MODEL 718-130
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OWB
2009-01-22
RADPRO ION
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OWB
2008-12-05
HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F
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OWB
2008-11-07
PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS
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OWB
2008-08-06
RFVISION, MODEL 9.9D
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OWB
2008-05-02
OEC 9900 ELITE
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OWB
2007-08-22
AXIOM LUMINOS DRF
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OWB
2007-05-18
CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)
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OWB
2007-03-09
TCA 5R / 5S
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OWB
2006-10-20
E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50
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OWB
2006-08-15
9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS
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OWB
2006-07-07
ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM
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OWB
2006-06-19
ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM
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OWB
2006-06-09
CPIVISION DIGITAL IMAGING SYSTEM
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OWB
2006-06-07
INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT
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OWB
2006-03-07
AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM
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OWB
2006-02-22
DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121
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OWB
2005-12-22
UROVANTAGE
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OWB
2005-10-26
MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR
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OWB
2005-09-16
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
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OWB
2005-05-26
ZIEHM QUANTUM
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OWB
2005-03-11
INNOVA 2100
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OWB
2004-12-22
GE OEC FLUOROSTAR
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OWB
2004-10-29
ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)
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OWB
2004-08-26
INNOVA 4100, INNOVA 3100
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OWB
2004-08-26
OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION
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OWB
2004-08-18
OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM
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OWB
2004-08-11
NEW BRID
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OWB
2004-06-30
PRECISION RXI ANALOG X-RAY SYSTEM
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OWB
2004-06-10
AXIOM ARTIS U
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OWB
2004-05-14
KMC-950 C-ARM MOBILE SYSTEM
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OWB
2003-12-09
ALLURA XPER FD20
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OWB
2003-11-19
GE PRECISION MPI
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OWB
2003-10-16
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
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OWB
2003-08-22
INNOVA 3100
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OWB
2003-07-17
PHILLIPS OMNIDIAGNOST ELEVA
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OWB
2003-05-21
RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM
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OWB
2003-04-07
PS 3000 DIGATAL PHOTOSPOT SYSTEM
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OWB
2003-01-16
INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
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OWB
2002-11-26
INNOVA 4100
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OWB
2002-10-08
INNOVA AND INNOVA 2000 S
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OWB
2002-09-17
IMPERIUM
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OWB
2002-09-17
OEC FLUOROTRAK 9800 PLUS
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OWB
2002-04-17
OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
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OWB
2002-02-12
ORION DIGITAL IMAGING SYSTEM
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OWB
2001-11-15
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
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OWB
2001-07-10
UROLOGIC
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OWB
2001-06-20
ZIEHM VISION
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OWB
2001-04-12
U04
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OWB
2001-03-12
PHILIPS BV PULSERA/ENDURA
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OWB
2000-10-17
FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS
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OWB
2000-09-06
PHILIPS INTEGRIS ALLURA
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OWB
2000-04-11
SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM
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OWB
2000-02-14
LCV+ VERSION 2
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OWB
1999-12-21
UROVIEW 2800
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OWB
1999-11-05
URF DIGITAL - OT
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OWB
1999-09-01
C-QUEST
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OWB
1998-11-02
PHILIPS DUO DIAGNOST
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OWB
1998-09-29
PHILIPS OMNIDIAGNOST
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OWB
1998-09-23
TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C
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OWB
1998-02-17
INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
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OWB
1997-04-21
SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS
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OWB
1997-03-11
SERIES 7600 MOBILE DIGITAL C-ARM
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OWB
1996-12-23
SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM
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OWB
1996-09-05
SKIN DOSE MONITOR
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OWB
1996-08-19
PHILIPS MULTIDIAGNOST 4
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OWB
1996-05-20
CLINIX MP
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OWB
1994-04-29
PHILIPS DCI-SX
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OWB
1994-03-16
TC+ SYSTEM (TILTING C-ARM SYSTEM)
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OWB
1992-09-15
UROSKOP D1, UROSKOP D2, AND UROSKOP D3
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OWB
1991-08-28
CSP
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