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
K
24
1249
Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)
2
Cleared 510(K)
K
23
3806
T2 Plus
2
Cleared 510(K)
K
24
0855
Dental Cone-beam Computed Tomography
2
Cleared 510(K)
K
23
2710
Dental Cone-beam Computed Tomography
2
Cleared 510(K)
K
23
0985
Planmeca Viso
2
Cleared 510(K)
K
23
1181
bright CT
2
Cleared 510(K)
K
23
2487
Provecta 3D Prime and Provecta 3D Prime Ceph
2
Cleared 510(K)
K
23
2166
PreXion3D Expedition
2
Cleared 510(K)
K
23
2287
RAYSCAN a-Expert3D
2
Cleared 510(K)
K
23
1796
Grreen X 12 (Model: PHT-75CHS)
2
Cleared 510(K)
K
22
2666
X-View 3D Pan/X-View 2D Pan
2
Cleared 510(K)
K
23
0505
Orthopantomograph™ OP 3D LX
2
Cleared 510(K)
K
23
0753
RCT800
2
Cleared 510(K)
K
22
3816
Dental CT Scanner AXR
2
Cleared 510(K)
K
22
3794
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
2
Cleared 510(K)
K
22
2150
PreXion3D Expedition
2
Cleared 510(K)
K
22
2219
R2 Studio Q/RCT820
2
Cleared 510(K)
K
22
1525
PreXion3D Explorer PRO
2
Cleared 510(K)
K
22
0392
PAPAYA 3D & PAPAYA 3D Plus
2
Cleared 510(K)
K
21
3278
Planmed Verity
2
Cleared 510(K)
K
21
3579
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
2
Cleared 510(K)
K
21
4084
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
2
Cleared 510(K)
K
21
1159
eco-x Series (eco-x, eco-x-s)
2
Cleared 510(K)
K
21
3226
RCT700
2
Cleared 510(K)
K
21
2254
DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
2
Cleared 510(K)
K
21
2303
T2
2
Cleared 510(K)
K
21
0820
EAGLE EDGE AXR90 and AXR120
2
Cleared 510(K)
K
20
0270
rainbow MCT
2
Cleared 510(K)
K
20
0271
rainbow CT
2
Cleared 510(K)
K
20
3784
PreXion3D Explorer PRO
2
Cleared 510(K)
K
21
0329
Green X 18(Model : PHT-75CHS)
2
Cleared 510(K)
K
20
1378
3D Accuitomo 150N
2
Cleared 510(K)
K
20
3797
vatech A9 (Model : PHT-30CSS)
2
Cleared 510(K)
K
20
1382
X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)
2
Cleared 510(K)
K
20
1627
Dental Computed Tomography X-Ray System, Green X
2
Cleared 510(K)
K
20
0469
PAPAYA 3D Premium & PAPAYA 3D Premium Plus
2
Cleared 510(K)
K
20
1667
Midmark Extraoral Imaging System (EOIS)
2
Cleared 510(K)
K
20
1140
Axeos
2
Cleared 510(K)
K
20
0688
hyperion X5, NewTom GO, X-RADiUS COMPACT
2
Cleared 510(K)
K
19
3329
PreXion3D Explorer EX
2
Cleared 510(K)
K
20
0183
CS 9600
2
Cleared 510(K)
K
19
3139
ProVecta 3D Prime Ceph
2
Cleared 510(K)
K
19
2737
RCT800
2
Cleared 510(K)
K
19
0856
SeeFactorCT3
2
Cleared 510(K)
K
18
3475
T1-CS, T1-C
2
Cleared 510(K)
K
19
1616
Orthophos S
2
Cleared 510(K)
K
19
0812
RAYSCAN a-Expert3D
2
Cleared 510(K)
K
19
0496
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
2
Cleared 510(K)
K
19
0320
PreXion3D Explorer
2
Cleared 510(K)
K
18
2805
RCT800
2
Cleared 510(K)
K
18
0918
Planmed Verity
2
Cleared 510(K)
K
18
0601
Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
2
Cleared 510(K)
K
18
2614
RCT700
2
Cleared 510(K)
K
18
1576
Planmeca Viso
2
Cleared 510(K)
K
18
1983
PreXion 3D Excelsior
2
Cleared 510(K)
K
18
1432
ProVectra 3D Prime with VistaSoft
2
Cleared 510(K)
K
18
1452
RCT800
2
Cleared 510(K)
K
18
0947
Orthopantomograph OP 3D
2
Cleared 510(K)
K
18
1136
CS 9600
2
Cleared 510(K)
K
17
3878
PreXion3D Excelsior
2
Cleared 510(K)
K
17
1012
Veraview X800
2
Cleared 510(K)
K
16
3423
Orthopantomograph OP300
2
Cleared 510(K)
K
17
0066
Green16/Green18 (Model: PHT-65LHS)
2
Cleared 510(K)
K
17
0813
ORTHOPANTOMOGRAPH OP 3D
2
Cleared 510(K)
K
16
1900
HYPERION X5
2
Cleared 510(K)
K
16
0166
X-MIND trium
2
Cleared 510(K)
K
16
2085
i-CAT FLX V series / KaVo 3D eXam+ V series
2
Cleared 510(K)
K
16
0882
PaX-i3D Green Premium (Model: PCT-90LH)
2
Cleared 510(K)
K
16
2660
Green Smart (Model: PHT-35LHS)
2
Cleared 510(K)
K
16
1881
PreXion3D Excelsior
2
Cleared 510(K)
K
16
0140
DENTRIa series
2
Cleared 510(K)
K
16
0525
RCT700
2
Cleared 510(K)
K
15
1137
X-VIEW, IMAGEN
2
Cleared 510(K)
K
16
0506
Planmeca ProMax 3D Max, Planmeca Maximity
2
Cleared 510(K)
K
15
1612
NewTom VGi evo
2
Cleared 510(K)
K
15
2489
ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray
2
Cleared 510(K)
K
15
0354
PAPAYA 3D Plus
2
Cleared 510(K)
K
15
2106
Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart
2
Cleared 510(K)
K
14
3435
Planmed Verity
2
Cleared 510(K)
K
15
0217
ORTHOPHOS SL
2
Cleared 510(K)
K
14
2247
RAYSCAN A-EXPERT 3D
2
Cleared 510(K)
K
13
3797
QMASTER-H/REVO
2
Cleared 510(K)
K
13
2983
TON-95LH, PAX-I3D ORTHO
2
Cleared 510(K)
K
13
3620
CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM
2
Cleared 510(K)
K
13
3544
OP300
2
Cleared 510(K)
K
13
3406
CS 8100 3D
2
Cleared 510(K)
K
13
1695
RAYSCAN A-EXPERT 3D
2
Cleared 510(K)
K
12
3332
NAOMI-CT
2
Cleared 510(K)
K
13
0442
NEWTOM VGI AND NEWTOM 5G
2
Cleared 510(K)
K
13
0443
I-MAX TOUCH 3D
2
Cleared 510(K)
K
13
0432
PHT-6500, PHT-60CFO
2
Cleared 510(K)
K
13
0297
SCANORA 3DX
2
Cleared 510(K)
K
12
3381
HYPERION X9
2
Cleared 510(K)
K
12
2199
PREXION3D ECLIPSE
2
Cleared 510(K)
K
12
3070
GALILEOS FAMILY
2
Cleared 510(K)
K
12
2981
RAYSCAN A-EXPERT 3D
2
Cleared 510(K)
K
12
0948
PREXION 3D
2
Cleared 510(K)
K
12
2018
OP300
2
Cleared 510(K)
K
12
2606
PHT-6500; PHT-60CFO; PAX-I3D
2
Cleared 510(K)
K
12
1400
PAX-UNI3D, PHT-7500
2
Cleared 510(K)
K
12
0753
CLARISCT
2
Cleared 510(K)
K
12
1412
PAX-FLEX3D, PHT-7000
2
Cleared 510(K)
K
12
1236
PAX-DUO3D PLUS, PCT-5000
2
Cleared 510(K)
K
10
3659
CS 9300, CS 9300C
2
Cleared 510(K)
K
10
1181
BEL-CAT
2
Cleared 510(K)
K
11
0839
SCANORA 3D
2
Cleared 510(K)
K
11
0260
NEWTOM 5G / NEWTOM 5G VERSION FP
2
Cleared 510(K)
K
10
2196
COMPUTED TOMOGRAPHY X-RAY SYSTEM
2
Cleared 510(K)
K
10
3711
ORTHOPHOS XG 3D / CEPH
2
Cleared 510(K)
K
09
0467
DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D
2
Cleared 510(K)
K
08
3917
X-RAY, TOMOGRAPHY, COMPUTED, DENTAL
2
Cleared 510(K)
K
09
0171
COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D
2
Cleared 510(K)
K
08
2410
MASTER3DS
2
Cleared 510(K)
K
08
2350
PAX-500
2
Cleared 510(K)
K
06
3622
FINECUBE DENTAL CT
2
Cleared 510(K)
K
06
3773
VOLUMETRIC TOMOGRAPHY
2
Cleared 510(K)
K
04
1137
NEWTOM 3G QR-DVT 9000
2
Cleared 510(K)
K
00
3787
NEWTOM QR-DVT 9000
2
Cleared 510(K)
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
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 30 November 2024 at 11:09 am
RA
/
subpart-b—diagnostic-devices
/
OAS
/
K082350
View Source
PAX-500
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082350
510(k) Type
Traditional
Applicant
VATECH CO., LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/10/2008
Days to Decision
56 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
K
24
1249
Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)
K
23
3806
T2 Plus
K
24
0855
Dental Cone-beam Computed Tomography
K
23
2710
Dental Cone-beam Computed Tomography
K
23
0985
Planmeca Viso
K
23
1181
bright CT
K
23
2487
Provecta 3D Prime and Provecta 3D Prime Ceph
K
23
2166
PreXion3D Expedition
K
23
2287
RAYSCAN a-Expert3D
K
23
1796
Grreen X 12 (Model: PHT-75CHS)
K
22
2666
X-View 3D Pan/X-View 2D Pan
K
23
0505
Orthopantomograph™ OP 3D LX
K
23
0753
RCT800
K
22
3816
Dental CT Scanner AXR
K
22
3794
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
K
22
2150
PreXion3D Expedition
K
22
2219
R2 Studio Q/RCT820
K
22
1525
PreXion3D Explorer PRO
K
22
0392
PAPAYA 3D & PAPAYA 3D Plus
K
21
3278
Planmed Verity
K
21
3579
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
K
21
4084
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
K
21
1159
eco-x Series (eco-x, eco-x-s)
K
21
3226
RCT700
K
21
2254
DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
K
21
2303
T2
K
21
0820
EAGLE EDGE AXR90 and AXR120
K
20
0270
rainbow MCT
K
20
0271
rainbow CT
K
20
3784
PreXion3D Explorer PRO
K
21
0329
Green X 18(Model : PHT-75CHS)
K
20
1378
3D Accuitomo 150N
K
20
3797
vatech A9 (Model : PHT-30CSS)
K
20
1382
X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)
K
20
1627
Dental Computed Tomography X-Ray System, Green X
K
20
0469
PAPAYA 3D Premium & PAPAYA 3D Premium Plus
K
20
1667
Midmark Extraoral Imaging System (EOIS)
K
20
1140
Axeos
K
20
0688
hyperion X5, NewTom GO, X-RADiUS COMPACT
K
19
3329
PreXion3D Explorer EX
K
20
0183
CS 9600
K
19
3139
ProVecta 3D Prime Ceph
K
19
2737
RCT800
K
19
0856
SeeFactorCT3
K
18
3475
T1-CS, T1-C
K
19
1616
Orthophos S
K
19
0812
RAYSCAN a-Expert3D
K
19
0496
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
K
19
0320
PreXion3D Explorer
K
18
2805
RCT800
K
18
0918
Planmed Verity
K
18
0601
Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
K
18
2614
RCT700
K
18
1576
Planmeca Viso
K
18
1983
PreXion 3D Excelsior
K
18
1432
ProVectra 3D Prime with VistaSoft
K
18
1452
RCT800
K
18
0947
Orthopantomograph OP 3D
K
18
1136
CS 9600
K
17
3878
PreXion3D Excelsior
K
17
1012
Veraview X800
K
16
3423
Orthopantomograph OP300
K
17
0066
Green16/Green18 (Model: PHT-65LHS)
K
17
0813
ORTHOPANTOMOGRAPH OP 3D
K
16
1900
HYPERION X5
K
16
0166
X-MIND trium
K
16
2085
i-CAT FLX V series / KaVo 3D eXam+ V series
K
16
0882
PaX-i3D Green Premium (Model: PCT-90LH)
K
16
2660
Green Smart (Model: PHT-35LHS)
K
16
1881
PreXion3D Excelsior
K
16
0140
DENTRIa series
K
16
0525
RCT700
K
15
1137
X-VIEW, IMAGEN
K
16
0506
Planmeca ProMax 3D Max, Planmeca Maximity
K
15
1612
NewTom VGi evo
K
15
2489
ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray
K
15
0354
PAPAYA 3D Plus
K
15
2106
Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart
K
14
3435
Planmed Verity
K
15
0217
ORTHOPHOS SL
K
14
2247
RAYSCAN A-EXPERT 3D
K
13
3797
QMASTER-H/REVO
K
13
2983
TON-95LH, PAX-I3D ORTHO
K
13
3620
CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM
K
13
3544
OP300
K
13
3406
CS 8100 3D
K
13
1695
RAYSCAN A-EXPERT 3D
K
12
3332
NAOMI-CT
K
13
0442
NEWTOM VGI AND NEWTOM 5G
K
13
0443
I-MAX TOUCH 3D
K
13
0432
PHT-6500, PHT-60CFO
K
13
0297
SCANORA 3DX
K
12
3381
HYPERION X9
K
12
2199
PREXION3D ECLIPSE
K
12
3070
GALILEOS FAMILY
K
12
2981
RAYSCAN A-EXPERT 3D
K
12
0948
PREXION 3D
K
12
2018
OP300
K
12
2606
PHT-6500; PHT-60CFO; PAX-I3D
K
12
1400
PAX-UNI3D, PHT-7500
K
12
0753
CLARISCT
K
12
1412
PAX-FLEX3D, PHT-7000
K
12
1236
PAX-DUO3D PLUS, PCT-5000
K
10
3659
CS 9300, CS 9300C
K
10
1181
BEL-CAT
K
11
0839
SCANORA 3D
K
11
0260
NEWTOM 5G / NEWTOM 5G VERSION FP
K
10
2196
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K
10
3711
ORTHOPHOS XG 3D / CEPH
K
09
0467
DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D
K
08
3917
X-RAY, TOMOGRAPHY, COMPUTED, DENTAL
K
09
0171
COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D
K
08
2410
MASTER3DS
K
08
2350
PAX-500
K
06
3622
FINECUBE DENTAL CT
K
06
3773
VOLUMETRIC TOMOGRAPHY
K
04
1137
NEWTOM 3G QR-DVT 9000
K
00
3787
NEWTOM QR-DVT 9000
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
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
/
OAS
/
K082350
View Source
PAX-500
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082350
510(k) Type
Traditional
Applicant
VATECH CO., LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/10/2008
Days to Decision
56 days
Submission Type
Summary