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
K
00
0412
VISION R/F TILTING TABLE
2
Cleared 510(K)
K
97
3039
LEGACY/LEGACY-D TABLE
2
Cleared 510(K)
K
97
1128
CAP-35B III/CINE 275
2
Cleared 510(K)
K
97
0640
PHILIPS EASY DIAGNOST
2
Cleared 510(K)
K
96
5105
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
2
Cleared 510(K)
K
96
5096
FLUOROVIEW SERIES FLUOROSCOPIC TABLES
2
Cleared 510(K)
K
96
3851
TILTING RADIOGRAPHIC TABLE (REMOTE)
2
Cleared 510(K)
K
96
1022
TANGENT VI TABLE
2
Cleared 510(K)
K
95
4356
COMPAX 90/15E
2
Cleared 510(K)
K
95
3557
SURGICAL C-ARM TABLE, 9610
2
Cleared 510(K)
K
95
3556
VACS TABLE, 9650
2
Cleared 510(K)
K
95
1176
KOORDINAT M
2
Cleared 510(K)
K
95
0981
ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650
2
Cleared 510(K)
K
95
0402
CORSINI 9090
2
Cleared 510(K)
K
94
5842
MOBILIX MOBILE X-RAY TABLE
2
Cleared 510(K)
K
94
3581
HYDRADJUST IV UROLOGICAL TABLE
2
Cleared 510(K)
K
94
4987
URO - ELITE TABLE ACCESSORIES
2
Cleared 510(K)
K
93
5444
OCTOSTOP(R) CHAIR (NEW MODEL
2
Cleared 510(K)
K
94
0721
CLINIX VP 4 TABLE
2
Cleared 510(K)
K
93
4574
MODEL MPFT-01, GENESIS
2
Cleared 510(K)
K
93
1563
SPECTRUM MARK I SPECIAL PROCEDURES TABLE
2
Cleared 510(K)
K
92
4326
ARTHRODYN 45 DEGREE X-RAY TABLE
2
Cleared 510(K)
K
92
5175
SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90
2
Cleared 510(K)
K
92
2591
UROLOGICAL C-ARM TABLE, MODEL #056-450
2
Cleared 510(K)
K
92
2364
DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST
2
Cleared 510(K)
K
92
0726
UROLOGICAL X-RAY TABLE HS-10A
2
Cleared 510(K)
K
92
0728
X-RAY DIAGNOSTIC TABLE YSF-100
2
Cleared 510(K)
K
92
0742
HYDRAJUST IV UROLOGICAL TABLE
2
Cleared 510(K)
K
92
0722
X-RAY DIAGNOSTIC TABLE YSF-200-30-90
2
Cleared 510(K)
K
91
4417
MEDIQUIP I.A. FIELD CONV KIT/AMSCO 2080 SER TABLE
2
Cleared 510(K)
K
91
2996
MODIF TOP DRIVE BOARD CXT-90 90/90 DIAG TILT TABLE
2
Cleared 510(K)
K
91
5853
TANGENT V
2
Cleared 510(K)
K
91
4165
X-RAY TABLE
2
Cleared 510(K)
K
91
2741
ELITE R 90/15
2
Cleared 510(K)
K
91
3147
SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100
2
Cleared 510(K)
K
91
0838
TREATMENT TABLE
2
Cleared 510(K)
K
91
2586
TANGENT IV
2
Cleared 510(K)
K
91
1098
PHILIPS URO DIAGNOST MRF
2
Cleared 510(K)
K
91
1267
RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004
2
Cleared 510(K)
K
90
5265
620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB
2
Cleared 510(K)
K
90
5501
ELITE 5000
2
Cleared 510(K)
K
90
5153
REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110
2
Cleared 510(K)
K
90
5152
REMOTE CONTROLLED X-RAY DIAG. RSZ-200
2
Cleared 510(K)
K
90
1654
MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE
2
Cleared 510(K)
K
90
2989
G.E. MONITROL 90 AND G.E. MONITROL 15
2
Cleared 510(K)
K
90
3422
MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE
2
Cleared 510(K)
K
90
3395
UROMAT 2000
2
Cleared 510(K)
K
89
6583
F.A.S.T. TABLE
2
Cleared 510(K)
K
89
6119
RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE
2
Cleared 510(K)
K
89
6324
ELITE 1500 RADIOGRAPHIC TILTING TABLE
2
Cleared 510(K)
K
89
3673
RMS 180
2
Cleared 510(K)
K
89
2226
TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE
2
Cleared 510(K)
K
88
4531
BETA 90/50 MOBILE IMAGING TABLE
2
Cleared 510(K)
K
88
3863
GENESIS 180
2
Cleared 510(K)
K
88
3162
TELESTATIX X-RAY TABLE
2
Cleared 510(K)
K
88
3153
UNDISTAT WITH EXPLORATOR 35 (UCS 35E)
2
Cleared 510(K)
K
88
2019
SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE
2
Cleared 510(K)
K
88
0529
CEILING MOUNTED TILTING TABLE TANGENT III
2
Cleared 510(K)
K
87
4114
TRAUMA TABLE II
2
Cleared 510(K)
K
87
4113
OMNI DIAGNOST
2
Cleared 510(K)
K
87
0707
PENTAMAX 1 MODEL B TABLE SYSTEM
2
Cleared 510(K)
K
85
4478
REI-90/90 RADIOGRAPHIC TABLE
2
Cleared 510(K)
K
86
0913
SIREGRAPH D
2
Cleared 510(K)
K
85
4486
TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE
2
Cleared 510(K)
K
85
4085
OMNI PLANE SYSTEM
2
Cleared 510(K)
K
85
3175
REI-90/15
2
Cleared 510(K)
K
85
0948
TILTING TABLE RADIOGRAPHIC A9006 TOMOJUPITER
2
Cleared 510(K)
K
84
3926
PRESTILIX 1690
2
Cleared 510(K)
K
84
0227
UROLIX-3 UROLOGICAL TABLE
2
Cleared 510(K)
K
84
0226
MOTOR TILTED EXAM. TABLE UV-56
2
Cleared 510(K)
K
79
2645
TRIOSKOP
2
Cleared 510(K)
K
79
2326
HILO TRANS-X TRAUMA TRANSPORT
2
Cleared 510(K)
K
79
1812
SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM
2
Cleared 510(K)
K
78
1532
UROSKOP A AND B
2
Cleared 510(K)
K
77
1293
X-RAY DIAG. TABLE DT-KCS
2
Cleared 510(K)
K
77
0334
TILTING X-RAY TABLE
2
Cleared 510(K)
K
76
0466
TABLE, X-RAY, RFX CLASSICAL
2
Cleared 510(K)
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
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 23 May 2025 at 11:06 pm
RA
/
subpart-b—diagnostic-devices
/
IXR
/
K883162
View Source
TELESTATIX X-RAY TABLE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K883162
510(k) Type
Traditional
Applicant
BAY X-RAY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/6/1988
Days to Decision
42 days
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
K
00
0412
VISION R/F TILTING TABLE
K
97
3039
LEGACY/LEGACY-D TABLE
K
97
1128
CAP-35B III/CINE 275
K
97
0640
PHILIPS EASY DIAGNOST
K
96
5105
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
K
96
5096
FLUOROVIEW SERIES FLUOROSCOPIC TABLES
K
96
3851
TILTING RADIOGRAPHIC TABLE (REMOTE)
K
96
1022
TANGENT VI TABLE
K
95
4356
COMPAX 90/15E
K
95
3557
SURGICAL C-ARM TABLE, 9610
K
95
3556
VACS TABLE, 9650
K
95
1176
KOORDINAT M
K
95
0981
ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650
K
95
0402
CORSINI 9090
K
94
5842
MOBILIX MOBILE X-RAY TABLE
K
94
3581
HYDRADJUST IV UROLOGICAL TABLE
K
94
4987
URO - ELITE TABLE ACCESSORIES
K
93
5444
OCTOSTOP(R) CHAIR (NEW MODEL
K
94
0721
CLINIX VP 4 TABLE
K
93
4574
MODEL MPFT-01, GENESIS
K
93
1563
SPECTRUM MARK I SPECIAL PROCEDURES TABLE
K
92
4326
ARTHRODYN 45 DEGREE X-RAY TABLE
K
92
5175
SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90
K
92
2591
UROLOGICAL C-ARM TABLE, MODEL #056-450
K
92
2364
DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST
K
92
0726
UROLOGICAL X-RAY TABLE HS-10A
K
92
0728
X-RAY DIAGNOSTIC TABLE YSF-100
K
92
0742
HYDRAJUST IV UROLOGICAL TABLE
K
92
0722
X-RAY DIAGNOSTIC TABLE YSF-200-30-90
K
91
4417
MEDIQUIP I.A. FIELD CONV KIT/AMSCO 2080 SER TABLE
K
91
2996
MODIF TOP DRIVE BOARD CXT-90 90/90 DIAG TILT TABLE
K
91
5853
TANGENT V
K
91
4165
X-RAY TABLE
K
91
2741
ELITE R 90/15
K
91
3147
SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100
K
91
0838
TREATMENT TABLE
K
91
2586
TANGENT IV
K
91
1098
PHILIPS URO DIAGNOST MRF
K
91
1267
RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004
K
90
5265
620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB
K
90
5501
ELITE 5000
K
90
5153
REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110
K
90
5152
REMOTE CONTROLLED X-RAY DIAG. RSZ-200
K
90
1654
MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE
K
90
2989
G.E. MONITROL 90 AND G.E. MONITROL 15
K
90
3422
MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE
K
90
3395
UROMAT 2000
K
89
6583
F.A.S.T. TABLE
K
89
6119
RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE
K
89
6324
ELITE 1500 RADIOGRAPHIC TILTING TABLE
K
89
3673
RMS 180
K
89
2226
TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE
K
88
4531
BETA 90/50 MOBILE IMAGING TABLE
K
88
3863
GENESIS 180
K
88
3162
TELESTATIX X-RAY TABLE
K
88
3153
UNDISTAT WITH EXPLORATOR 35 (UCS 35E)
K
88
2019
SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE
K
88
0529
CEILING MOUNTED TILTING TABLE TANGENT III
K
87
4114
TRAUMA TABLE II
K
87
4113
OMNI DIAGNOST
K
87
0707
PENTAMAX 1 MODEL B TABLE SYSTEM
K
85
4478
REI-90/90 RADIOGRAPHIC TABLE
K
86
0913
SIREGRAPH D
K
85
4486
TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE
K
85
4085
OMNI PLANE SYSTEM
K
85
3175
REI-90/15
K
85
0948
TILTING TABLE RADIOGRAPHIC A9006 TOMOJUPITER
K
84
3926
PRESTILIX 1690
K
84
0227
UROLIX-3 UROLOGICAL TABLE
K
84
0226
MOTOR TILTED EXAM. TABLE UV-56
K
79
2645
TRIOSKOP
K
79
2326
HILO TRANS-X TRAUMA TRANSPORT
K
79
1812
SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM
K
78
1532
UROSKOP A AND B
K
77
1293
X-RAY DIAG. TABLE DT-KCS
K
77
0334
TILTING X-RAY TABLE
K
76
0466
TABLE, X-RAY, RFX CLASSICAL
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
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
/
IXR
/
K883162
View Source
TELESTATIX X-RAY TABLE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K883162
510(k) Type
Traditional
Applicant
BAY X-RAY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/6/1988
Days to Decision
42 days