Product Code: JAA FDA class 2 21 CFR 892.1650

System, X-Ray, Fluoroscopic, Image-Intensified

Radiology

An image-intensified fluoroscopic X-ray system uses an electronic image intensifier to amplify the fluoroscopic image, enabling real-time visualization of dynamic processes such as contrast studies, catheterizations, and interventional procedures at reduced radiation doses. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JAA, regulated under 21 CFR 892.1650, within the Radiology medical specialty. This device is eligible for third-party review.

510(k)s
298
FEI Numbers
139
Registration Numbers
139
Unique Applicants
165
Years Active
48

Basic Information

Product Code
JAA
Device Class
FDA class 2
Regulation Number
892.1650
Medical Specialty
Radiology
Review Panel
RA
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 298 510(k) clearances via K numbers.

K Number Device Name
K242488 Soteria E-View
K242948 Adora DRFi (04550010)
K233380 TRIDENT Mobile Fluoroscopy System
K233945 ProxiDiagnost N90 / Precision CRF (706110, 706400)
K232910 CombiDiagnost R90
K232526 XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
K220871 Nautilus
K212890 Nyquist.IQ
K212837 ProxiDiagnost N90
K212145 DR 800 with DSA, DR 800
K210469 Insight Agile DRF
K203428 Ziehm Vision RFD
K203010 Platinum dRF Imaging System
K200965 XR-MX/1000
K203087 CombiDiagnost R90
K202235 ArtPIX DRF
K200396 Insight Enhanced DRF Digital Imaging System
K191713 CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)
K191504 PowerDR
K191877 FLUOROspeed
K191310 Insight Essentials DRF Digital Imaging System
K182834 CS-series-FP with Optional ROI Accessory CA-100S
K190373 SonialVision G4
K173395 MECALL CLISIS SYSTEMS, Discovery RF180
K180651 Uroview FD II
K180589 DR 800 with MUSICA Dynamic
K163210 Philips CombiDiagnost R90
K161019 Uroview FD
K160301 Platinum dRF Imaging System
K150306 D2RS_AT Digital Dynamic Remote System
K151485 GENESIS
K142341 X-RAY TV SYSTEM SONIALVISION G4
K133434 GENESIS II
K140380 OPERA SWING
K141541 XIDF-AWS801, ANGIO WORKSTATION, V5.31
K132289 GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM
K133553 KALARE
K131075 X-RAY TV SYSTEM SONIAL VISION G4
K131766 PLATINUM DRF IMAGING SYSTEM
K132904 ZIEHM VISION RFD
K132106 INFINIX ANGIO WORKSTATION W/DTS SOFTWARE
K130318 NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)
K123097 DOSE TRACKING SYSTEM MODEL XIDF-DTS801
K122768 GENESIS
K121293 CS-SERIES-FP WITH 3030+OPTION
K112054 INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V
K111292 LUMINOS AGILE
K110785 KALARE DIAGNOSTIC X-RAY TABLE SYSTEM
K103038 DUET DRF
K101491 UROSKOP OMNIA
K082830 INFX-8000H, INFINIX-I
K081621 INFX-8000C (INFINIX CC-I AND VC-I)
K081491 SMITH & NEPHEW CDS SYSTEM
K081582 INFX-8000V, INFINIX-CFI AND INFINIX VFI
K081091 PRECISION 500D R&F X-RAY SYSTEM
K080859 DRF 4343
K070390 FLUOROPRO RF DIGITAL IMAGING SYSTEM
K061028 PRECISION THUNIS 800+
K052610 IMAGE STAR II
K051602 AXIOM SIRESKOP SD
K051136 SMITH & NEPHEW CDS SYSTEM
K051025 FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
K050866 CENTRION 500 C-ARM SYSTEM
K050692 FLXIS
K042698 UNFORS PATIENT SKIN DOSIMETER (PSD)
K040870 SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS
K024012 OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
K022911 MODEL AMI1200 C-ARM
K022899 PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0
K022565 TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
K021021 MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
K020055 PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION
K012424 SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
K010772 ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM
K011624 EXPEDIO 500D R&F X-RAY SYSTEM
K010392 ATHENA REMOTE CONTROLLED RF SYSTEM
K010187 KIMAX, MODEL 1024
K004037 X-RAY SYSTEM XR-MX
K000987 VFSS IMAGER, MODEL SIS-300
K993896 MCA-601, C-ARM MOBILE
K992603 XRT 600 R/F, WRF 0600
K993038 TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)
K990055 B-400 CEILING MOUNTED POSSITIONER, MODEL B-400
K982319 CAREGRAPH
K982345 VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM
K981414 LC POSITIONER
K982028 FLUOROSPOT COMPACT
K981227 SYMPHONY 360 REMOTE CONTROL TABLE
K974058 FS IV MINI C-ARM SYSTEM
K973744 UNICATH SP BI-PLANE (MODEL M269 & M289)
K973067 DRTS REMOTE CONTROL DRAPE
K973073 DRTS IMAGE INTENSIFIER DRAPE
K972442 CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002
K970947 B-350 CEILING MOUNTED C-POSITIONER
K970608 EVT MARKER BOARD
K961782 BIO-BINKI
K964990 HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)
K964322 VIPOR UNIT
K963888 C-ARM TABLE IVS-100
K963617 SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120
K961140 FLUOROPLUS CARDIAC TV
K953974 CAMVISION 1000
K961207 EP-X BIPLANE
K962606 TOPOGRAPHIC IMAGING MARKER
K962140 ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM MODEL NO. 6896.300
K961690 CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105
K961193 FULL FRAME ZOOM SYSTEM
K955687 RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY
K953113 SBDX MOBILE FLUOROSCOPY SYSTEM
K951261 DFI-1000 AND DVS-475 IMAGING DEVICES
K960266 SIREGRAPH CF
K954945 HANEL MAVIG MONITOR SUSPENSION SYSTEM
K954590 MAX-1000A/R1
K953950 FLUORO CATHETER
K952493 FLUORECORD MODEL 762
K952456 IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
K950781 COMPACT 7600
K946081 FLUOREX DTA-400A
K951358 SIRESKOP SX
K936236 SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES
K950683 ARTHROGRAM TRAY
K943156 SYSTEM, IMAGE PROCESSING
K950971 MOBIL C-ARM, REGURBISHED, VARIOUS MODELS
K950631 ID400 SERIES ARMBOARDS
K945460 PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION
K941917 FLUOROPLUA CARDIAC AND/OR INSTAVIEW
K942019 MODEL FP-100
K943272 VISUALIZER 2000
K944973 NRF SYSTEM
K943532 PANORAMIC CORPORATION HDLX
K943447 V-MAX OPTIONS
K943805 PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD
K940295 UROVIEW MODEL 2600
K942841 OEC 901
K942674 ANGIOREST TABLE PAD SYSTEM
K942264 DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION)
K941611 TDA-4000/A4
K926560 EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER
K933472 SHIMADZU DIGITAL SUBSTRACTION SYST DAR-2400 SERIES
K936136 UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE
K933473 CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM
K933791 PHILIPS ANGIOPRO RELEASE 2.1
K934626 GOODALL LASER TARGETING DEVICE
K933100 ARC-600
K934481 EP-X
K933299 QL MULTIPULSE 2048
K932445 SIRESKOP CX
K931941 SUNSCOPE 100
K931268 URETERAL COMPRESSION DEVICE
K930885 PNEUMATIC COMPRESSION DEVICE
K926064 FLUOROSCOPIC BRIGHTNESS STABALIZER/FBS MODEL 9205A
K926434 SIS-300(N)-DIA SCAN
K926122 FLUOREX
K924879 EP 3000
K925251 LIXI IMAGING SCOPE. MODIFICATION
K923107 BODY BAND RESTRAINT STRAP SET
K922977 EXPOSET
K924164 DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT
K923585 DIGITAL FLUORO STORE
K922274 MEDRAD PATHFINDER-E ROADMAPPING SYSTEM
K923454 SHIMADZU IMAGE AMPLIFIER IA-9LS SERIES
K923453 SHIMADZU IMAGE AMPLIFIER IA-9LM SERIES
K923137 CSL X-RAY IMAGESCOPE
K922240 ELECTRONIC PHOTOSPOT 20
K920746 VFC UNIT
K922012 SHIMADZU IMAGE AMPLIFIER IA-12VSA SERIES
K922013 SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES
K922011 SHIMADZU IMAGE AMPLIFIER IA-12VDA SERIES
K920720 DIGITAL RADIOGRAPHY SYSTEM IDR-1000
K920721 DIGITAL RADIOGRAPHY SYSTEM IDR-2000
K920550 DISPLAY PROCESSOR - MODEL IDP5100
K915405 P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS)
K914414 VIDEO FLUOROSCOPE
K913886 SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDER
K915592 PEGASUS LATERAL CARDIAC POSITIONER
K914446 UROVIEW 2000, MODIFICATION
K905694 FVP-1000 FAMILY AND FVP-1000D FAMILY
K914525 FLUROSPOT H VERSION 2
K913012 DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES
K912896 DIGISTORE 2100
K912341 MULTICAM I 8X10
K912470 PHILIPS DIAGNOST 96
K912380 LASER BEAM LOCALIZER FOR SIREMOBIL 4
K911454 FC2000
K910384 VIDEO ANNOTATOR MODEL PK2310
K905278 STS(TM) FLUOROSCOPIC IMAGING MODULE
K905111 DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES
K904986 PROGRAMMABLE VIDEO CONTROLLER MODEL PK2060
K904012 PHILIPS INTEGRIS I 2000 SYSTEM
K902982 G.E. POLARIX II C-ARM
K903821 PSC-1 W/OTHER NUMERICAL
K902981 G.E. FLUOROCON 300 IMAGING SYSTEM
K902983 SIEMEN'S SIREMOBILE II C-ARM
K902980 G.E. XT CEILING TUBE SUSPENSION
K902583 JOINT MOTON IMAGER(TM)
K902005 MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE
K901671 HAFCON (FLOURO FOOTSWITCH)
K902927 DIGITAL PHOTOSPOT
K902535 SONY WBS-700H VIDEOCASSETTE RECORDER SYSTEM
K901405 DIGIFORMER HR DFP-50A
K901323 HYDRA VIEW IMAGING SYSTEM
K901153 SONY VO-5800H VIDEOCASSETTE RECORDER
K900893 CARDIOVUE CFS-100
K896331 V2465P X-RAY IMAGE INTENSIFIER
K895546 MODIFIED SPANTRON FRAME FREEZE
K895394 MOBILE X-RAY TELEVISION UNIT WHA-10A/B
K895730 X-RAY EQUIPMENT (VARIOUS TYPES)
K894913 DA-100HS
K893475 UROVIEW II
K893644 PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER
K893476 ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV.
K893131 DIGITAL SPOT IMAGING (DSI)
K884598 SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200
K884028 MULTI CAMERA CONTROL UNIT (MCCU)
K890878 PHOTOMULITPLIER TUBE INTERFACE P.C. BOARD
K890745 SC-1000 WITH SUFFIXES (SCAN CONVERTER)
K884578 POLARIX 2 AND POLARIX 2E
K883580 UNIVERSAL ABC CONTROLER
K884317 MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM
K883372 ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
K883985 CARDIAC CX
K883161 HIMOBILIX 2N
K882311 SHIMADZU LATERAL C-ARM MH-31
K882175 HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP
K882176 VTR-12
K880527 CEILING MOUNTED FLUOROSCOPIC C-ARM ARIEL C-ARM
K874905 P2020 MOBILE C-ARM IMAGE INTENSIFIER
K874901 REVELATION, RADIO FLUOROSCOPIC X-RAY EXAM TABLE
K875157 SHIMADZU CATHETERIZATION C-ARM STAND MH-50A
K873985 FLUORO COVER
K872061 LP LATERAL FLUORO POSITIONER (B5077A)
K871743 VIDEO PLUS MODELS VP500, VP500A AND VP1000
K871911 THE F SPOON HAND HELD FLUOROSCOPIC COMPRESSION
K871127 DTV-4112 FLUOROSCOPIC TELEVISION CAMERA
K870869 DTV-411OP
K871119 CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D
K863853 EAZY COVERS
K870429 EUSEK-BUSH IN-BATH FILMING DEVICE (#MC-00186)
K864749 TELAMAT
K864837 MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM
K864584 FLUOROVISION CONTRAST ENHANCER
K862120 SCX SYSTEM
K861785 FLUOROSCOPE BAND BAG
K854953 DIAMED MODELS 600, 900, 960, 964
K852346 XISCAN MODEL 1000
K855213 PET-SCOPE II IMAGE INTENSIFIER
K853984 CANON X-RAY IMAGE DISTRIBUTOR
K851031 EXPOSCOP MOBILE IMAGING SYSTEM
K850959 EQUIPMENT SNAP KOVERS
K844375 EIGEN FLORO-STOR FS-100
K843920 FLUOROSCAN/TM BY HEALTHMATE
K843972 ANGIOPLUS-S
K843917 FLUOROSCOPIC AUTOMATIC BRIGHTNESS CNTL
K843235 STENOSCOP
K842217 IDAS DIGITAL FLUOROSCOPIC IMAGINS SYS
K842191 DIGISTORE 50
K840621 FLUOROSCOPIC IMAGE INTENSIFIER
K840225 C-ARM CEILING CRANE FT-2
K840364 REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY
K840191 DIGITAL FLUOROGRAPHY X-RAY SYSTEM
K840134 CAMTEX 1000
K840390 TECHNICARE MODEL 1047
K834287 DIGITAL RADIOGRAPHY SYS-DPS7100
K834286 BI-PLANE DIGITAL FLUOROGRAPHY DFX7000
K833641 IMAGE INTENSIFIER TUBE W/HOUSING &
K833531 CT SCANNING ACCESSORIES
K833237 DIGITAL RADIOGRAPHY SYS DUAL GANTRIES
K833530 DIGITAL FLUOROGRAPHIC X-RAY SYSTEM
K833230 REGISTREX 1000 DIGITAL RADIOGRAPHY SYS
K827489 HYPERLUX 30 IMAGE SYSTEM
K820178 PI808 MOBILE C-ARM IMAGE INTENSIFIER
K820184 LATERAL ANGULATING FLUORO SUSPENSION
K813158 RDP-2000
K813217 DIGITAL FLUROGRAPHIC IMAGING SYSTEM
K812963 IBIS II
K812775 FLUORICON L300 IMAGE INTENSIFIER
K812561 LATERAL ANGULATING FLUORO SUSPENSION SYS
K812217 FLUORO AUTOMATIC BRIGHTNESS SYS
K811094 CARDIAC 1000 TM
K811295 DIGITAL NOISE REDUCER
K810716 X-RAY IMAGE INTENSIFIER PRODUCTS
K810364 DIGITAL RADIOGRAPHY SYSTEM
K810189 SIRECON COMPACT
K802953 DIGITAL FLUOROGRAPHIC X-RAY SYSTEM
K802150 DIGITAL RADIOGRAPHY SYSTEM
K801948 DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM
K801320 SFX-90 TABLE/SPOTFILMER W/FLUORICON L200
K801166 PET-SCOPE II MODEL DIS-1611
K800639 ORBITOR
K792225 P1806 MOBILE C-ARM IMAGE INTENSIFIER
K791830 L/U ARM - NEURO - VASCULAR #B5080B
K781711 EVALUSKOP
K771485 PET-TV X-RAY IMAGE INTENSIFIER SYSTEM
K771298 6 L.L. SYSTEM
K771096 TELHTHERAPY SIMULATOR AECL-CP, G-3200
K770337 FLUOROSCOPIC ASSEMBLY, IMAGE INTENS.
K770333 FLUOROSCOPE, C-ARM
K761285 PET-SCOPE

FEI Numbers

This FDA classification entry is associated with 139 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 139 registration numbers. Click on an entry to view related FDA registrations.