System, X-Ray, Fluoroscopic, Image-Intensified
FDA product code JAA · 291 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
- 1976-12-29 – 2026-05-29
JAA
2026-05-29
JAA
2025-09-16
Insight Enhanced™ DRF (EN-1002-01)
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JAA
2025-01-06
Soteria E-View
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JAA
2024-12-23
Adora DRFi (04550010)
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JAA
2024-06-26
TRIDENT Mobile Fluoroscopy System
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JAA
2024-01-11
ProxiDiagnost N90 / Precision CRF (706110, 706400)
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JAA
2023-10-19
CombiDiagnost R90
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JAA
2023-09-12
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
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JAA
2022-04-18
Nautilus
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JAA
2021-12-13
Nyquist.IQ
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JAA
2021-09-21
ProxiDiagnost N90
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JAA
2021-08-31
DR 800 with DSA, DR 800
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JAA
2021-07-27
Insight Agile DRF
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JAA
2021-03-17
Ziehm Vision RFD
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JAA
2021-01-22
Platinum dRF Imaging System
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JAA
2020-12-29
XR-MX/1000
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JAA
2020-12-03
CombiDiagnost R90
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JAA
2020-09-03
ArtPIX DRF
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JAA
2020-03-06
Insight Enhanced DRF Digital Imaging System
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JAA
2019-10-04
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)
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JAA
2019-08-16
PowerDR
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JAA
2019-08-05
FLUOROspeed
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JAA
2019-06-10
Insight Essentials DRF Digital Imaging System
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JAA
2019-03-29
CS-series-FP with Optional ROI Accessory CA-100S
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JAA
2019-03-15
SonialVision G4
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JAA
2018-05-21
MECALL CLISIS SYSTEMS, Discovery RF180
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JAA
2018-04-12
Uroview FD II
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JAA
2018-04-05
DR 800 with MUSICA Dynamic
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JAA
2017-01-31
Philips CombiDiagnost R90
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JAA
2016-08-17
Uroview FD
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JAA
2016-03-04
Platinum dRF Imaging System
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JAA
2013-12-12
PLATINUM DRF IMAGING SYSTEM
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JAA
2013-12-05
ZIEHM VISION RFD
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JAA
2013-11-12
INFINIX ANGIO WORKSTATION W/DTS SOFTWARE
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JAA
2013-04-22
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)
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JAA
2013-02-13
DOSE TRACKING SYSTEM MODEL XIDF-DTS801
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JAA
2013-01-18
GENESIS
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JAA
2012-07-26
CS-SERIES-FP WITH 3030+OPTION
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JAA
2011-08-05
INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V
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JAA
2011-06-03
LUMINOS AGILE
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JAA
2011-05-27
KALARE DIAGNOSTIC X-RAY TABLE SYSTEM
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JAA
2011-03-29
DUET DRF
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JAA
2010-06-30
UROSKOP OMNIA
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JAA
2008-10-10
INFX-8000H, INFINIX-I
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JAA
2008-06-23
INFX-8000C (INFINIX CC-I AND VC-I)
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JAA
2008-06-19
SMITH & NEPHEW CDS SYSTEM
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JAA
2008-06-17
INFX-8000V, INFINIX-CFI AND INFINIX VFI
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JAA
2008-06-11
PRECISION 500D R&F X-RAY SYSTEM
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JAA
2008-06-04
DRF 4343
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JAA
2007-04-05
FLUOROPRO RF DIGITAL IMAGING SYSTEM
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JAA
2006-06-07
PRECISION THUNIS 800+
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JAA
2005-11-30
IMAGE STAR II
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JAA
2005-07-07
AXIOM SIRESKOP SD
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JAA
2005-07-01
SMITH & NEPHEW CDS SYSTEM
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JAA
2005-05-13
FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
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JAA
2005-04-27
CENTRION 500 C-ARM SYSTEM
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JAA
2005-04-08
FLXIS
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JAA
2004-10-22
UNFORS PATIENT SKIN DOSIMETER (PSD)
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JAA
2004-05-17
SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS
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JAA
2003-03-20
OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
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JAA
2002-12-02
MODEL AMI1200 C-ARM
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JAA
2002-11-22
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0
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JAA
2002-10-08
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
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JAA
2002-06-06
MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
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JAA
2002-03-15
PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION
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JAA
2001-10-18
SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
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JAA
2001-08-23
ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM
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JAA
2001-06-08
EXPEDIO 500D R&F X-RAY SYSTEM
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JAA
2001-03-12
ATHENA REMOTE CONTROLLED RF SYSTEM
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JAA
2001-02-14
KIMAX, MODEL 1024
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JAA
2001-02-02
X-RAY SYSTEM XR-MX
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JAA
2000-06-01
VFSS IMAGER, MODEL SIS-300
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JAA
2000-03-27
MCA-601, C-ARM MOBILE
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JAA
1999-10-25
XRT 600 R/F, WRF 0600
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JAA
1999-10-07
TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)
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JAA
1999-02-02
B-400 CEILING MOUNTED POSSITIONER, MODEL B-400
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JAA
1998-09-22
CAREGRAPH
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JAA
1998-09-01
VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM
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JAA
1998-07-16
LC POSITIONER
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JAA
1998-07-14
FLUOROSPOT COMPACT
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JAA
1998-06-30
SYMPHONY 360 REMOTE CONTROL TABLE
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JAA
1998-01-12
FS IV MINI C-ARM SYSTEM
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JAA
1997-12-29
UNICATH SP BI-PLANE (MODEL M269 & M289)
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JAA
1997-10-16
DRTS REMOTE CONTROL DRAPE
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JAA
1997-10-08
DRTS IMAGE INTENSIFIER DRAPE
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JAA
1997-09-11
CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002
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JAA
1997-05-14
B-350 CEILING MOUNTED C-POSITIONER
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JAA
1997-04-21
EVT MARKER BOARD
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JAA
1997-03-28
BIO-BINKI
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JAA
1997-02-26
HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)
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JAA
1997-02-26
VIPOR UNIT
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JAA
1996-12-18
C-ARM TABLE IVS-100
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JAA
1996-11-08
SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120
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JAA
1996-09-20
FLUOROPLUS CARDIAC TV
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JAA
1996-09-09
CAMVISION 1000
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JAA
1996-08-20
EP-X BIPLANE
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JAA
1996-08-07
TOPOGRAPHIC IMAGING MARKER
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JAA
1996-07-25
ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM MODEL NO. 6896.300
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JAA
1996-06-27
CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105
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JAA
1996-06-17
FULL FRAME ZOOM SYSTEM
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