FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
EAG
Cephalometer
2
Product Code
EAH
Cone, Radiographic, Lead-Lined
1
Product Code
EAP
Unit, X-Ray, Intraoral
2
Product Code
EHB
Collimator, X-Ray
1
Product Code
EHD
Unit, X-Ray, Extraoral With Timer
2
Product Code
MUH
System, X-Ray, Extraoral Source, Digital
2
Product Code
EAM
Screen, Intensifying, Radiographic
1
Product Code
EGT
Controller, Temperature, Radiographic
2
Product Code
EGW
Dryer, Film, Radiographic
2
Product Code
EGY
Processor, Radiographic-Film, Automatic, Dental
2
Product Code
HBK
Chair, Pneumoencephalographic
2
Product Code
ITX
Transducer, Ultrasonic, Diagnostic
2
Product Code
ITY
Assembly, Tube Housing, X-Ray, Diagnostic
1
Product Code
IWN
Cassette, Measurement, Ardran-Crooks
1
Product Code
IWY
Holder, Head, Radiographic
1
Product Code
IWZ
Film, Radiographic
1
Product Code
IXA
Cassette, Radiographic Film
2
Product Code
IXC
Illuminator, Radiographic-Film
1
Product Code
IXD
Source, Calibration, Sealed, Nuclear
1
Product Code
IXF
Test-Pattern, Radiographic
1
Product Code
IXG
Phantom, Anthropomorphic, Radiographic
1
Product Code
IXH
Camera, Focal Spot, Radiographic
1
Product Code
IXJ
Grid, Radiographic
1
Product Code
IXK
System, Imaging, X-Ray, Electrostatic
2
Product Code
IXL
Device, Spot-Film
2
Product Code
IXO
Synchronizer, Ecg / Respirator, Radiographic
1
Product Code
IXQ
Table, Radiographic, Stationary Top
2
Product Code
IXR
Table, Radiographic, Tilting
2
Product Code
IXW
Processor, Radiographic-Film, Automatic
2
Product Code
IXX
Processor, Cine Film
2
Product Code
IXY
Holder, Radiographic Cassette, Wall-Mounted
1
Product Code
IYB
Tube Mount, X-Ray, Diagnostic
1
Product Code
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
2
Product Code
IYO
System, Imaging, Pulsed Echo, Ultrasonic
2
Product Code
IYP
Phantom, Anthropomorphic, Nuclear
1
Product Code
IYQ
Phantom, Flood Source, Nuclear
1
Product Code
IYT
System, Rebreathing, Radionuclide
2
Product Code
IYW
Scanner, Rectilinear, Nuclear
1
Product Code
IYX
Camera, Scintillation (Gamma)
1
Product Code
IYY
Synchronizer, Electrocardiograph, Nuclear
1
Product Code
IYZ
Bed, Scanning, Nuclear
1
Product Code
IZC
Camera, Positron
1
Product Code
IZD
Probe, Uptake, Nuclear
1
Product Code
IZF
System, X-Ray, Tomographic
2
Product Code
IZG
System, X-Ray, Photofluorographic
2
Product Code
IZH
System, X-Ray, Mammographic
2
Product Code
IZI
System, X-Ray, Angiographic
2
Product Code
IZJ
Camera, X-Ray, Fluorographic, Cine Or Spot
2
Product Code
IZL
System, X-Ray, Mobile
2
Product Code
IZO
Generator, High-Voltage, X-Ray, Diagnostic
1
Product Code
IZP
Programmer, Changer, Film/Cassette, Radiographic
2
Product Code
IZS
Aperture, Radiographic
2
Product Code
IZT
Cone, Radiographic
2
Product Code
IZW
Collimator, Automatic, Radiographic
2
Product Code
IZX
Collimator, Manual, Radiographic
2
Product Code
IZZ
Table, Radiographic, Non-Tilting, Powered
2
Product Code
JAA
System, X-Ray, Fluoroscopic, Image-Intensified
2
Product Code
JAB
System, X-Ray, Fluoroscopic, Non-Image-Intensified
2
Product Code
JAC
System, X-Ray, Film Marking, Radiographic
1
Product Code
JAF
Monitor, Ultrasonic, Nonfetal
2
Product Code
JAG
Illuminator, Radiographic-Film, Explosion-Proof
1
Product Code
JAK
System, X-Ray, Tomography, Computed
2
Product Code
JAM
Scanner, Whole Body, Nuclear
1
Product Code
JAN
Counter, Whole Body, Nuclear
1
Product Code
JAO
Scanner, Fluorescent
2
Product Code
JAR
Phantom, Test-Pattern, Radionuclide
1
Product Code
JWM
System, Tomographic, Nuclear
2
Product Code
KGI
Densitometer, Bone
2
Product Code
KPR
System, X-Ray, Stationary
2
Product Code
KPS
System, Tomography, Computed, Emission
2
Product Code
KPT
Calibrator, Dose, Radionuclide
2
Product Code
KPW
Device, Beam Limiting, X-Ray, Diagnostic
2
Product Code
KPX
Changer, Radiographic Film/Cassette
2
Product Code
KXH
Cradle, Patient, Radiologic
1
Product Code
KXJ
Table, Radiologic
2
Product Code
LEK
Transilluminator (Diaphanoscope)
3
Product Code
LHO
Instrument, Quality-Assurance, Radiologic
1
Product Code
LLZ
System, Image Processing, Radiological
2
Product Code
LMA
Digitizer, Image, Radiological
2
Product Code
LMB
Device, Digital Image Storage, Radiological
1
Product Code
LMC
Camera, Multi Format, Radiological
2
Product Code
LMD
System, Digital Image Communications, Radiological
1
Product Code
LNH
System, Nuclear Magnetic Resonance Imaging
2
Product Code
LNI
System, Nuclear Magnetic Resonance Spectroscopic
2
Product Code
LQA
Media, Reusable Image
1
Product Code
MOS
Coil, Magnetic Resonance, Specialty
2
Product Code
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
2
Product Code
MUA
Bone Sonometer
2
Product Code
MUE
Full Field Digital, System, X-Ray, Mammographic
2
Product Code
MUI
Media, Coupling, Ultrasound
2
Product Code
MWP
Cabinet, X-Ray System
2
Product Code
MYN
Analyzer, Medical Image
2
Product Code
NCS
System, Imaging, Holography, Acoustic
2
Product Code
NWE
Colon Computed Tomography System, Computer Aided Detection
2
Product Code
OAS
X-Ray, Tomography, Computed, Dental
2
Product Code
OEB
Lung Computed Tomography System, Computer-Aided Detection
2
Product Code
OII
Arthrogram Tray
2
Product Code
OIJ
Biopsy Needle Guide Kit
2
Product Code
OIK
Radiology Dental Tray
2
Product Code
OIL
Discography Kit
2
Product Code
OIM
Mri Disposable Kit
2
Product Code
OIO
Radiographic Contrast Tray
2
Product Code
OIP
Radiology-Diagnostic Kit
2
Product Code
OMJ
Chest X-Ray Computer Aided Detection
2
Product Code
OQQ
Diagnostic Ultrasonic Transducer, Robotic
2
Product Code
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
2
Product Code
OWB
Interventional Fluoroscopic X-Ray System
2
Product Code
OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
2
Product Code
K
23
3669
OEC 3D
2
Cleared 510(K)
K
21
3113
Orthoscan Tau Mini C-Arm
2
Cleared 510(K)
K
20
3346
OEC 3D
2
Cleared 510(K)
K
19
2819
OEC Elite
2
Cleared 510(K)
K
19
0024
Smart-C
2
Cleared 510(K)
K
18
3220
OrthoScan TAU Mini C-Arm
2
Cleared 510(K)
K
18
2626
OEC One
2
Cleared 510(K)
K
17
0946
Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant
2
Cleared 510(K)
K
17
2550
OEC Elite
2
Cleared 510(K)
K
17
1800
OEC Elite MiniView
2
Cleared 510(K)
K
16
3429
B6
2
Cleared 510(K)
K
16
0984
MultiScan G-Arm System
2
Cleared 510(K)
K
16
0131
OEC Elite MiniView
2
Cleared 510(K)
K
16
0065
GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
2
Cleared 510(K)
K
15
1280
MultiScan G-Arm System
2
Cleared 510(K)
K
14
1672
DIGIARC 100AU+
2
Cleared 510(K)
K
13
3174
ORTHOSCAN FD MINI C-ARM
2
Cleared 510(K)
K
13
1423
G-ARM MULTISCAN SYSTEM
2
Cleared 510(K)
K
12
3603
OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME
2
Cleared 510(K)
K
12
1303
MOBILE C-ARM
2
Cleared 510(K)
K
12
0613
OEC 9900 ELITE
2
Cleared 510(K)
K
12
0388
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
2
Cleared 510(K)
K
11
3708
ORTHOSCAN MOBILE DI MINI C-ARM
2
Cleared 510(K)
K
09
2564
O-ARM IMAGING SYSTEM
2
Cleared 510(K)
K
06
1873
VERT-X
2
Cleared 510(K)
K
06
0344
O-ARM IMAGING SYSTEM
2
Cleared 510(K)
K
05
1754
ORTHOSCAN, ORTHOSCAN HD
2
Cleared 510(K)
K
05
1490
GE OEC EVERVIEW 7500
2
Cleared 510(K)
K
05
1133
ARCADIS AVANTIC
2
Cleared 510(K)
K
05
0996
O-ARM IMAGING SYSTEM
2
Cleared 510(K)
K
04
3379
SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200
2
Cleared 510(K)
K
04
1213
3DSCOPE
2
Cleared 510(K)
K
04
0347
SIREMOBIL ISO-C 3D
2
Cleared 510(K)
K
04
0066
SIREMOBILE C06
2
Cleared 510(K)
K
03
3066
XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
2
Cleared 510(K)
K
01
3426
MOONRAY MOBILE C-ARM
2
Cleared 510(K)
K
01
0762
PHILIPS BV LIBRA
2
Cleared 510(K)
K
01
0393
APOLLO MOBILE C ARM SYSTEM
2
Cleared 510(K)
K
00
3837
FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM
2
Cleared 510(K)
K
00
3568
XISCAN 6000 IMAGING SYSTEM
2
Cleared 510(K)
K
00
3266
SIREMOBIL ISO-C 3D
2
Cleared 510(K)
K
99
3092
SONADA ULTRASOUND SYSTEM
2
Cleared 510(K)
K
99
2506
MINI 6800 DIGITAL MOBILE C-ARM
2
Cleared 510(K)
K
98
4406
XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM
2
Cleared 510(K)
K
98
2706
PHILIPS BV300 SERIES RELEASE 2.1
2
Cleared 510(K)
K
98
1131
PATHFINDER MOBILE C ARM
2
Cleared 510(K)
K
98
0322
ACCENT 16, ACCENT 22
2
Cleared 510(K)
K
97
3598
SIREMOBIL CO2
2
Cleared 510(K)
K
96
5013
DIGISCOPE RX-2 (9 OPTION)
2
Cleared 510(K)
K
96
3093
SIREMOBIL COMPACT
2
Cleared 510(K)
K
96
0907
ORCA
2
Cleared 510(K)
K
95
5251
OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM
2
Cleared 510(K)
K
96
0198
DIGISCOPE RX-2
2
Cleared 510(K)
K
95
3910
PHILIPS BV 300 SERIES
2
Cleared 510(K)
K
95
1765
SERIES 6600 DIGITAL MOBILE C-ARM
2
Cleared 510(K)
K
94
0294
SHIMADZU MOBILE X-RAY SYSTEMS
2
Cleared 510(K)
K
93
5580
PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER
2
Cleared 510(K)
K
93
4700
MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY
2
Cleared 510(K)
K
93
3431
ORTHOTRAC COAXIAL LASER
2
Cleared 510(K)
K
93
3447
STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM
2
Cleared 510(K)
K
92
6056
9600 FLUOROSCOPIC IMAGING SYSTEM
2
Cleared 510(K)
K
91
4748
COMET C-125
2
Cleared 510(K)
K
92
1255
PHILIPS BV26 MOBILE C-ARM STAND
2
Cleared 510(K)
K
91
3525
MOBILE X-RAY SYSTEM
2
Cleared 510(K)
K
91
1739
SWEMAC REISON BIPLANAR 300
2
Cleared 510(K)
K
91
0115
PHILIPS BV-29 IMAGING SYSTEM
2
Cleared 510(K)
K
90
0967
MODIFIED ALPHA MC-9R C-ARM
2
Cleared 510(K)
K
90
0193
MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT
2
Cleared 510(K)
K
90
0194
MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
2
Cleared 510(K)
K
89
6387
SXT-60F/60M MOBILE C ARM X-RAY UNIT
2
Cleared 510(K)
K
89
2934
1 VIDEO TAPE RECORDER MODEL BK-224 H
2
Cleared 510(K)
K
89
3617
MOBILE C-ARM
2
Cleared 510(K)
K
88
0518
MOBILE C-ARM OMNI 325
2
Cleared 510(K)
K
82
0658
LIXISCOPE - OR LIXI
2
Cleared 510(K)
K
76
0429
FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS.
2
Cleared 510(K)
PGY
Display, Diagnostic Radiology
2
Product Code
POK
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
2
Product Code
QAS
Radiological Computer-Assisted Triage And Notification Software
2
Product Code
QFM
Radiological Computer-Assisted Prioritization Software For Lesions
2
Product Code
QHA
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
2
Product Code
QHX
Fluoroscopic X-Ray Image Intensifier
1
Product Code
QHY
Solid State Fluoroscopic X-Ray Imager
2
Product Code
QIH
Automated Radiological Image Processing Software
2
Product Code
QKB
Radiological Image Processing Software For Radiation Therapy
2
Product Code
RCC
C-Arm Fluoroscopic X-Ray System
2
Product Code
QTZ
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
2
Product Code
QXL
Cabinet, Emission Computed Tomography System
2
Product Code
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 6 December 2024 at 11:05 pm
RA
/
subpart-b—diagnostic-devices
/
OXO
/
K984406
View Source
XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K984406
510(k) Type
Traditional
Applicant
XITEC, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/2/1999
Days to Decision
55 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
Miscellaneous
Subpart B—Diagnostic Devices
EAG
Cephalometer
EAH
Cone, Radiographic, Lead-Lined
EAP
Unit, X-Ray, Intraoral
EHB
Collimator, X-Ray
EHD
Unit, X-Ray, Extraoral With Timer
MUH
System, X-Ray, Extraoral Source, Digital
EAM
Screen, Intensifying, Radiographic
EGT
Controller, Temperature, Radiographic
EGW
Dryer, Film, Radiographic
EGY
Processor, Radiographic-Film, Automatic, Dental
HBK
Chair, Pneumoencephalographic
ITX
Transducer, Ultrasonic, Diagnostic
ITY
Assembly, Tube Housing, X-Ray, Diagnostic
IWN
Cassette, Measurement, Ardran-Crooks
IWY
Holder, Head, Radiographic
IWZ
Film, Radiographic
IXA
Cassette, Radiographic Film
IXC
Illuminator, Radiographic-Film
IXD
Source, Calibration, Sealed, Nuclear
IXF
Test-Pattern, Radiographic
IXG
Phantom, Anthropomorphic, Radiographic
IXH
Camera, Focal Spot, Radiographic
IXJ
Grid, Radiographic
IXK
System, Imaging, X-Ray, Electrostatic
IXL
Device, Spot-Film
IXO
Synchronizer, Ecg / Respirator, Radiographic
IXQ
Table, Radiographic, Stationary Top
IXR
Table, Radiographic, Tilting
IXW
Processor, Radiographic-Film, Automatic
IXX
Processor, Cine Film
IXY
Holder, Radiographic Cassette, Wall-Mounted
IYB
Tube Mount, X-Ray, Diagnostic
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
IYO
System, Imaging, Pulsed Echo, Ultrasonic
IYP
Phantom, Anthropomorphic, Nuclear
IYQ
Phantom, Flood Source, Nuclear
IYT
System, Rebreathing, Radionuclide
IYW
Scanner, Rectilinear, Nuclear
IYX
Camera, Scintillation (Gamma)
IYY
Synchronizer, Electrocardiograph, Nuclear
IYZ
Bed, Scanning, Nuclear
IZC
Camera, Positron
IZD
Probe, Uptake, Nuclear
IZF
System, X-Ray, Tomographic
IZG
System, X-Ray, Photofluorographic
IZH
System, X-Ray, Mammographic
IZI
System, X-Ray, Angiographic
IZJ
Camera, X-Ray, Fluorographic, Cine Or Spot
IZL
System, X-Ray, Mobile
IZO
Generator, High-Voltage, X-Ray, Diagnostic
IZP
Programmer, Changer, Film/Cassette, Radiographic
IZS
Aperture, Radiographic
IZT
Cone, Radiographic
IZW
Collimator, Automatic, Radiographic
IZX
Collimator, Manual, Radiographic
IZZ
Table, Radiographic, Non-Tilting, Powered
JAA
System, X-Ray, Fluoroscopic, Image-Intensified
JAB
System, X-Ray, Fluoroscopic, Non-Image-Intensified
JAC
System, X-Ray, Film Marking, Radiographic
JAF
Monitor, Ultrasonic, Nonfetal
JAG
Illuminator, Radiographic-Film, Explosion-Proof
JAK
System, X-Ray, Tomography, Computed
JAM
Scanner, Whole Body, Nuclear
JAN
Counter, Whole Body, Nuclear
JAO
Scanner, Fluorescent
JAR
Phantom, Test-Pattern, Radionuclide
JWM
System, Tomographic, Nuclear
KGI
Densitometer, Bone
KPR
System, X-Ray, Stationary
KPS
System, Tomography, Computed, Emission
KPT
Calibrator, Dose, Radionuclide
KPW
Device, Beam Limiting, X-Ray, Diagnostic
KPX
Changer, Radiographic Film/Cassette
KXH
Cradle, Patient, Radiologic
KXJ
Table, Radiologic
LEK
Transilluminator (Diaphanoscope)
LHO
Instrument, Quality-Assurance, Radiologic
LLZ
System, Image Processing, Radiological
LMA
Digitizer, Image, Radiological
LMB
Device, Digital Image Storage, Radiological
LMC
Camera, Multi Format, Radiological
LMD
System, Digital Image Communications, Radiological
LNH
System, Nuclear Magnetic Resonance Imaging
LNI
System, Nuclear Magnetic Resonance Spectroscopic
LQA
Media, Reusable Image
MOS
Coil, Magnetic Resonance, Specialty
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
MUA
Bone Sonometer
MUE
Full Field Digital, System, X-Ray, Mammographic
MUI
Media, Coupling, Ultrasound
MWP
Cabinet, X-Ray System
MYN
Analyzer, Medical Image
NCS
System, Imaging, Holography, Acoustic
NWE
Colon Computed Tomography System, Computer Aided Detection
OAS
X-Ray, Tomography, Computed, Dental
OEB
Lung Computed Tomography System, Computer-Aided Detection
OII
Arthrogram Tray
OIJ
Biopsy Needle Guide Kit
OIK
Radiology Dental Tray
OIL
Discography Kit
OIM
Mri Disposable Kit
OIO
Radiographic Contrast Tray
OIP
Radiology-Diagnostic Kit
OMJ
Chest X-Ray Computer Aided Detection
OQQ
Diagnostic Ultrasonic Transducer, Robotic
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
OWB
Interventional Fluoroscopic X-Ray System
OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
K
23
3669
OEC 3D
K
21
3113
Orthoscan Tau Mini C-Arm
K
20
3346
OEC 3D
K
19
2819
OEC Elite
K
19
0024
Smart-C
K
18
3220
OrthoScan TAU Mini C-Arm
K
18
2626
OEC One
K
17
0946
Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant
K
17
2550
OEC Elite
K
17
1800
OEC Elite MiniView
K
16
3429
B6
K
16
0984
MultiScan G-Arm System
K
16
0131
OEC Elite MiniView
K
16
0065
GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
K
15
1280
MultiScan G-Arm System
K
14
1672
DIGIARC 100AU+
K
13
3174
ORTHOSCAN FD MINI C-ARM
K
13
1423
G-ARM MULTISCAN SYSTEM
K
12
3603
OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME
K
12
1303
MOBILE C-ARM
K
12
0613
OEC 9900 ELITE
K
12
0388
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
K
11
3708
ORTHOSCAN MOBILE DI MINI C-ARM
K
09
2564
O-ARM IMAGING SYSTEM
K
06
1873
VERT-X
K
06
0344
O-ARM IMAGING SYSTEM
K
05
1754
ORTHOSCAN, ORTHOSCAN HD
K
05
1490
GE OEC EVERVIEW 7500
K
05
1133
ARCADIS AVANTIC
K
05
0996
O-ARM IMAGING SYSTEM
K
04
3379
SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200
K
04
1213
3DSCOPE
K
04
0347
SIREMOBIL ISO-C 3D
K
04
0066
SIREMOBILE C06
K
03
3066
XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
K
01
3426
MOONRAY MOBILE C-ARM
K
01
0762
PHILIPS BV LIBRA
K
01
0393
APOLLO MOBILE C ARM SYSTEM
K
00
3837
FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM
K
00
3568
XISCAN 6000 IMAGING SYSTEM
K
00
3266
SIREMOBIL ISO-C 3D
K
99
3092
SONADA ULTRASOUND SYSTEM
K
99
2506
MINI 6800 DIGITAL MOBILE C-ARM
K
98
4406
XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM
K
98
2706
PHILIPS BV300 SERIES RELEASE 2.1
K
98
1131
PATHFINDER MOBILE C ARM
K
98
0322
ACCENT 16, ACCENT 22
K
97
3598
SIREMOBIL CO2
K
96
5013
DIGISCOPE RX-2 (9 OPTION)
K
96
3093
SIREMOBIL COMPACT
K
96
0907
ORCA
K
95
5251
OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM
K
96
0198
DIGISCOPE RX-2
K
95
3910
PHILIPS BV 300 SERIES
K
95
1765
SERIES 6600 DIGITAL MOBILE C-ARM
K
94
0294
SHIMADZU MOBILE X-RAY SYSTEMS
K
93
5580
PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER
K
93
4700
MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY
K
93
3431
ORTHOTRAC COAXIAL LASER
K
93
3447
STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM
K
92
6056
9600 FLUOROSCOPIC IMAGING SYSTEM
K
91
4748
COMET C-125
K
92
1255
PHILIPS BV26 MOBILE C-ARM STAND
K
91
3525
MOBILE X-RAY SYSTEM
K
91
1739
SWEMAC REISON BIPLANAR 300
K
91
0115
PHILIPS BV-29 IMAGING SYSTEM
K
90
0967
MODIFIED ALPHA MC-9R C-ARM
K
90
0193
MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT
K
90
0194
MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
K
89
6387
SXT-60F/60M MOBILE C ARM X-RAY UNIT
K
89
2934
1 VIDEO TAPE RECORDER MODEL BK-224 H
K
89
3617
MOBILE C-ARM
K
88
0518
MOBILE C-ARM OMNI 325
K
82
0658
LIXISCOPE - OR LIXI
K
76
0429
FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS.
PGY
Display, Diagnostic Radiology
POK
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
QAS
Radiological Computer-Assisted Triage And Notification Software
QFM
Radiological Computer-Assisted Prioritization Software For Lesions
QHA
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
QHX
Fluoroscopic X-Ray Image Intensifier
QHY
Solid State Fluoroscopic X-Ray Imager
QIH
Automated Radiological Image Processing Software
QKB
Radiological Image Processing Software For Radiation Therapy
RCC
C-Arm Fluoroscopic X-Ray System
QTZ
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
QXL
Cabinet, Emission Computed Tomography System
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous Devices
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
RA
/
subpart-b—diagnostic-devices
/
OXO
/
K984406
View Source
XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K984406
510(k) Type
Traditional
Applicant
XITEC, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/2/1999
Days to Decision
55 days
Submission Type
Summary