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Innolitics
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
Hematology
Review Panel
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Review Panel
Microbiology
Review Panel
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Review Panel
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Review Panel
Ophthalmic
Review Panel
Orthopedic
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Pathology
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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
K
95
4666
MPH50, MPH65, AND MPH80
1
Cleared 510(K)
K
95
3582
HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR
1
Cleared 510(K)
K
95
3831
N 800 HF
1
Cleared 510(K)
K
95
2822
SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G
1
Cleared 510(K)
K
95
2265
MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR
1
Cleared 510(K)
K
95
0883
POLYDOROS SX 65 AND 80
1
Cleared 510(K)
K
95
0694
COMPACT-X
1
Cleared 510(K)
K
95
0291
DIGITAL 625HF
1
Cleared 510(K)
K
95
0041
SII 360 APR
1
Cleared 510(K)
K
95
0040
SII 525 APR
1
Cleared 510(K)
K
94
5453
UD 150L-R II
1
Cleared 510(K)
K
94
5452
UD 150L-F
1
Cleared 510(K)
K
95
0037
N 800 HF
1
Cleared 510(K)
K
94
5731
HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS
1
Cleared 510(K)
K
94
5668
KXO-80G
1
Cleared 510(K)
K
94
2731
SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR
1
Cleared 510(K)
K
94
4150
MICRO X-65 HF
1
Cleared 510(K)
K
94
4149
MICRO X-80 HF
1
Cleared 510(K)
K
94
4148
MICRO X-30HF
1
Cleared 510(K)
K
94
4147
MICRO X-50 HF
1
Cleared 510(K)
K
94
3652
VASCULAR MP X-RAY GENERATOR
1
Cleared 510(K)
K
94
3504
RSX-525HF
1
Cleared 510(K)
K
94
2778
MODEL VPW2877F8, MAMMO 5 POWER SUPPLY
1
Cleared 510(K)
K
94
2100
MODEL TM EP HIGH VOLTAGE GENERATOR
1
Cleared 510(K)
K
93
4686
MOLYBDENUM/RHODIUM FILTERS
1
Cleared 510(K)
K
94
0227
SCPU X-RAY GENERATOR
1
Cleared 510(K)
K
93
5068
RADIOGRAPHIC GENERATOR HFQ-WHIS
1
Cleared 510(K)
K
93
4967
SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR
1
Cleared 510(K)
K
93
3777
CONCEPT ONE
1
Cleared 510(K)
K
93
3471
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G
1
Cleared 510(K)
K
93
3650
PHILIPS XRG 90 X-RAY GENERATOR SYSTEM
1
Cleared 510(K)
K
93
3240
POLYDOROS IS
1
Cleared 510(K)
K
93
1930
POYDOROS LX
1
Cleared 510(K)
K
93
1998
LCR GENERATOR
1
Cleared 510(K)
K
93
1049
ADVANTX SYSTEM
1
Cleared 510(K)
K
93
0792
RSX 30HF
1
Cleared 510(K)
K
92
6365
MAGMA XHF-30, XHF-40, XHF-50
1
Cleared 510(K)
K
92
0349
PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR
1
Cleared 510(K)
K
92
0351
PCX 650HF RADIOGRAPHIC X-RAY
1
Cleared 510(K)
K
92
5684
OLYMP-X,X-RAY GENERATOR
1
Cleared 510(K)
K
92
4078
POLYDOROS C
1
Cleared 510(K)
K
92
5844
PHILIPS SUPER CP FAMILY
1
Cleared 510(K)
K
92
5105
PHILIPS MEDIO CP FAMILY
1
Cleared 510(K)
K
92
3786
POLYDOROS XS50 AND SX80
1
Cleared 510(K)
K
92
1875
X-RAY CONTROL AND HI-VOLTAGE GENERATOR
1
Cleared 510(K)
K
92
2814
TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT
1
Cleared 510(K)
K
92
2165
ATC725, ATC525, AND AP300
1
Cleared 510(K)
K
92
1951
MPG 65-80-100 X-RAY GENERATOR AND CONTROL
1
Cleared 510(K)
K
92
1516
P2900 X-RAY GENERATOR
1
Cleared 510(K)
K
92
0730
X-RAY HIGH VOLTAGE GENERATOR ED 125L
1
Cleared 510(K)
K
91
5339
GEN-X 800/300
1
Cleared 510(K)
K
91
5227
GEN-X 800/500
1
Cleared 510(K)
K
91
3222
OPTIMA
1
Cleared 510(K)
K
91
4266
MICRO-X 30 HF
1
Cleared 510(K)
K
91
4236
MICRO-X 50 HF
1
Cleared 510(K)
K
91
3577
MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR
1
Cleared 510(K)
K
91
3578
MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR
1
Cleared 510(K)
K
91
4302
GEN-X 800/650
1
Cleared 510(K)
K
91
4301
GEN-X 800/800
1
Cleared 510(K)
K
91
1562
EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR
1
Cleared 510(K)
K
91
3234
VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY
1
Cleared 510(K)
K
91
3065
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L
1
Cleared 510(K)
K
91
3062
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10
1
Cleared 510(K)
K
91
3063
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-10
1
Cleared 510(K)
K
91
3064
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L
1
Cleared 510(K)
K
91
2449
MICRO-X 15 HF
1
Cleared 510(K)
K
91
1280
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B
1
Cleared 510(K)
K
91
0650
SELECTOR MD (50KW AND 80 KW)
1
Cleared 510(K)
K
91
1339
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K
1
Cleared 510(K)
K
91
0020
CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS
1
Cleared 510(K)
K
91
0820
VPW 2877E6 X-RAY POWER SUPPLY
1
Cleared 510(K)
K
90
5695
MICRO-X 80HF
1
Cleared 510(K)
K
90
5799
HFQ SERIES CONTROLS AND GENERATORS
1
Cleared 510(K)
K
90
4169
VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY
1
Cleared 510(K)
K
90
5855
VPW2877E7 X RAY POWER SUPPLY
1
Cleared 510(K)
K
90
2986
G.E. DXD 325/350/350II/DXD 525/525II GENERATORS
1
Cleared 510(K)
K
90
4114
ANATECH X-RAY GENERATOR
1
Cleared 510(K)
K
90
2987
G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS
1
Cleared 510(K)
K
90
2988
G.E. MSI 850/850II/1250 THREE PHASE GENERATORS
1
Cleared 510(K)
K
90
2985
G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN
1
Cleared 510(K)
K
90
4043
KXO-80C/80D
1
Cleared 510(K)
K
90
4397
TEC 1410
1
Cleared 510(K)
K
90
3942
SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G
1
Cleared 510(K)
K
90
2106
VPW 2877D5, X-RAY POWER SUPPLY
1
Cleared 510(K)
K
90
2637
FUTURUS 2001 X-RAY GENERATOR
1
Cleared 510(K)
K
90
1951
MODEL# MPC
1
Cleared 510(K)
K
90
0062
U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL
1
Cleared 510(K)
K
89
5969
RADKOR DXG-650R
1
Cleared 510(K)
K
89
4479
30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE
1
Cleared 510(K)
K
89
3681
MAMM-AIRE CP
1
Cleared 510(K)
K
89
3674
RME 325R
1
Cleared 510(K)
K
89
2657
SENSIMAT
1
Cleared 510(K)
K
89
2943
MULTI PULSE POWER UNIT GENERATOR
1
Cleared 510(K)
K
89
0083
GX-2000 STATIONARY X-RAY GENERATOR
1
Cleared 510(K)
K
89
0066
STAR 36
1
Cleared 510(K)
K
88
4678
ESP 3-PHASE X-RAY GENERATORS
1
Cleared 510(K)
K
88
3976
CFX 625
1
Cleared 510(K)
K
88
4134
MICRO-X 100CP
1
Cleared 510(K)
K
88
3431
RAYMAX 2100 MODELS 2130 & 2136
1
Cleared 510(K)
K
88
3154
SELDIX 325 TWO PULSE GENERATOR/CONTROL
1
Cleared 510(K)
K
88
3081
RADKOR, XG-515
1
Cleared 510(K)
K
88
1696
RADKOR XG-325
1
Cleared 510(K)
K
88
0525
3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF
1
Cleared 510(K)
K
88
1886
MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L
1
Cleared 510(K)
K
88
1387
X-RAY GENERATING SYSTEM, TF 800
1
Cleared 510(K)
K
88
1386
X-RAY GENERATING SYSTEM TF 1000
1
Cleared 510(K)
K
88
1795
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K
1
Cleared 510(K)
K
88
0519
SINGLE PHASE DIAG. X-RAY GENERATOR MICRO-X 650
1
Cleared 510(K)
K
88
0522
THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80
1
Cleared 510(K)
K
88
0521
SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-650
1
Cleared 510(K)
K
88
0524
THREE PHASE DIAGNOSTIC X-RAY GENERATOR MICRO-X 100
1
Cleared 510(K)
K
88
0523
THREE PHASE, DIAGNOSTIC GENERATOR MICRO-X 75
1
Cleared 510(K)
K
88
0532
SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX 350
1
Cleared 510(K)
K
87
4946
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60
1
Cleared 510(K)
K
88
0050
EDEC 60R
1
Cleared 510(K)
K
87
5341
EDEC 60 R/F
1
Cleared 510(K)
K
87
5342
EDEC 90C
1
Cleared 510(K)
K
87
3544
MPG-50 X-RAY GENERATOR
1
Cleared 510(K)
K
87
2445
POWER-AID INDEPENDENT X-RAY POWER SOURCE
1
Cleared 510(K)
K
86
4624
PROBE, UPTAKE, NUCLEAR
1
Cleared 510(K)
K
87
2357
TRANSWORLD 360V, MODEL A1-4040
1
Cleared 510(K)
K
87
1145
EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR
1
Cleared 510(K)
K
87
0851
EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR
1
Cleared 510(K)
K
86
4339
PORTA RAY MODEL 325
1
Cleared 510(K)
K
86
2800
SMX GENERATOR
1
Cleared 510(K)
K
86
2682
MVP GENERATOR, CATALOG NO. H8018
1
Cleared 510(K)
K
85
4499
GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR
1
Cleared 510(K)
K
86
0736
FISCHER IMAGING FX325R X-RAY GENERATOR
1
Cleared 510(K)
K
86
0203
TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR
1
Cleared 510(K)
K
85
2908
EDEC 2000
1
Cleared 510(K)
K
85
1011
HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR
1
Cleared 510(K)
K
85
0823
SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR
1
Cleared 510(K)
K
85
0117
XMA 325 (X-RAY GENERATOR)
1
Cleared 510(K)
K
84
3443
EDEC-100
1
Cleared 510(K)
K
84
2348
SPX GENERATOR
1
Cleared 510(K)
K
83
3846
PROCESS 100 ST
1
Cleared 510(K)
K
82
0593
ESP SERIES (X-RAY GENERATORS
1
Cleared 510(K)
K
82
0307
TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE
1
Cleared 510(K)
K
82
0112
SIEMENS POLYDOROS 800
1
Cleared 510(K)
K
81
3051
COMPTAR III
1
Cleared 510(K)
K
81
2616
POLYPHOS 500
1
Cleared 510(K)
K
81
1198
ECCO GENERATOR
1
Cleared 510(K)
K
80
2996
VECTOR-100 X-RAY GENERATOR
1
Cleared 510(K)
K
80
2941
CINESCOPE III RADIOGRAPHIC GENERATOR
1
Cleared 510(K)
K
80
2548
GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80
1
Cleared 510(K)
K
80
2551
GENERATOR, HIGH VOLT, X-RAY, MPX100/125
1
Cleared 510(K)
K
80
2550
GENERATOR, HIGH VOLT, X-RAY, MPX 125
1
Cleared 510(K)
K
80
2549
GENERATOR, HIGH VOLT, X-RAY, MPX 100
1
Cleared 510(K)
K
80
1808
BR 2002 X-RAY GENERATOR SYSTEM
1
Cleared 510(K)
K
80
1408
CINESCOPE III
1
Cleared 510(K)
K
79
2393
GIGANTOS 1012 MP
1
Cleared 510(K)
K
79
2392
POLYPHOS
1
Cleared 510(K)
K
79
1933
CONVERSION CONTRACTOR TIMER KIT
1
Cleared 510(K)
K
79
1214
TRIDOROS 712
1
Cleared 510(K)
K
78
0742
INTRAORAL DENTAL X-RAY GENERATOR
1
Cleared 510(K)
K
77
1294
X-RAY GENERATOR MODEL KXO-15
1
Cleared 510(K)
K
77
1295
X-RAY GENERATOR MODEL KX0-825
1
Cleared 510(K)
K
77
0338
X-RAY CONTROL & X-RAY HV GENERATOR
1
Cleared 510(K)
K
77
0007
MPX 100
1
Cleared 510(K)
K
77
0008
MPX 125
1
Cleared 510(K)
K
77
0006
MPX 80
1
Cleared 510(K)
K
76
0569
THREE PHASE X-RAY CONTROLS & HV GENERATORS
1
Cleared 510(K)
K
76
0568
SINGLE PHASE X-RAY CONTROLS & HV GENERATORS
1
Cleared 510(K)
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 16 May 2025 at 11:05 pm
RA
/
subpart-b—diagnostic-devices
/
IZO
/
K902106
View Source
VPW 2877D5, X-RAY POWER SUPPLY
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K902106
510(k) Type
Traditional
Applicant
VARIAN ASSOC., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/10/1990
Days to Decision
94 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
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
K
95
4666
MPH50, MPH65, AND MPH80
K
95
3582
HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR
K
95
3831
N 800 HF
K
95
2822
SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G
K
95
2265
MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR
K
95
0883
POLYDOROS SX 65 AND 80
K
95
0694
COMPACT-X
K
95
0291
DIGITAL 625HF
K
95
0041
SII 360 APR
K
95
0040
SII 525 APR
K
94
5453
UD 150L-R II
K
94
5452
UD 150L-F
K
95
0037
N 800 HF
K
94
5731
HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS
K
94
5668
KXO-80G
K
94
2731
SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR
K
94
4150
MICRO X-65 HF
K
94
4149
MICRO X-80 HF
K
94
4148
MICRO X-30HF
K
94
4147
MICRO X-50 HF
K
94
3652
VASCULAR MP X-RAY GENERATOR
K
94
3504
RSX-525HF
K
94
2778
MODEL VPW2877F8, MAMMO 5 POWER SUPPLY
K
94
2100
MODEL TM EP HIGH VOLTAGE GENERATOR
K
93
4686
MOLYBDENUM/RHODIUM FILTERS
K
94
0227
SCPU X-RAY GENERATOR
K
93
5068
RADIOGRAPHIC GENERATOR HFQ-WHIS
K
93
4967
SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR
K
93
3777
CONCEPT ONE
K
93
3471
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G
K
93
3650
PHILIPS XRG 90 X-RAY GENERATOR SYSTEM
K
93
3240
POLYDOROS IS
K
93
1930
POYDOROS LX
K
93
1998
LCR GENERATOR
K
93
1049
ADVANTX SYSTEM
K
93
0792
RSX 30HF
K
92
6365
MAGMA XHF-30, XHF-40, XHF-50
K
92
0349
PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR
K
92
0351
PCX 650HF RADIOGRAPHIC X-RAY
K
92
5684
OLYMP-X,X-RAY GENERATOR
K
92
4078
POLYDOROS C
K
92
5844
PHILIPS SUPER CP FAMILY
K
92
5105
PHILIPS MEDIO CP FAMILY
K
92
3786
POLYDOROS XS50 AND SX80
K
92
1875
X-RAY CONTROL AND HI-VOLTAGE GENERATOR
K
92
2814
TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT
K
92
2165
ATC725, ATC525, AND AP300
K
92
1951
MPG 65-80-100 X-RAY GENERATOR AND CONTROL
K
92
1516
P2900 X-RAY GENERATOR
K
92
0730
X-RAY HIGH VOLTAGE GENERATOR ED 125L
K
91
5339
GEN-X 800/300
K
91
5227
GEN-X 800/500
K
91
3222
OPTIMA
K
91
4266
MICRO-X 30 HF
K
91
4236
MICRO-X 50 HF
K
91
3577
MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR
K
91
3578
MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR
K
91
4302
GEN-X 800/650
K
91
4301
GEN-X 800/800
K
91
1562
EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR
K
91
3234
VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY
K
91
3065
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L
K
91
3062
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10
K
91
3063
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-10
K
91
3064
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L
K
91
2449
MICRO-X 15 HF
K
91
1280
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B
K
91
0650
SELECTOR MD (50KW AND 80 KW)
K
91
1339
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K
K
91
0020
CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS
K
91
0820
VPW 2877E6 X-RAY POWER SUPPLY
K
90
5695
MICRO-X 80HF
K
90
5799
HFQ SERIES CONTROLS AND GENERATORS
K
90
4169
VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY
K
90
5855
VPW2877E7 X RAY POWER SUPPLY
K
90
2986
G.E. DXD 325/350/350II/DXD 525/525II GENERATORS
K
90
4114
ANATECH X-RAY GENERATOR
K
90
2987
G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS
K
90
2988
G.E. MSI 850/850II/1250 THREE PHASE GENERATORS
K
90
2985
G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN
K
90
4043
KXO-80C/80D
K
90
4397
TEC 1410
K
90
3942
SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G
K
90
2106
VPW 2877D5, X-RAY POWER SUPPLY
K
90
2637
FUTURUS 2001 X-RAY GENERATOR
K
90
1951
MODEL# MPC
K
90
0062
U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL
K
89
5969
RADKOR DXG-650R
K
89
4479
30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE
K
89
3681
MAMM-AIRE CP
K
89
3674
RME 325R
K
89
2657
SENSIMAT
K
89
2943
MULTI PULSE POWER UNIT GENERATOR
K
89
0083
GX-2000 STATIONARY X-RAY GENERATOR
K
89
0066
STAR 36
K
88
4678
ESP 3-PHASE X-RAY GENERATORS
K
88
3976
CFX 625
K
88
4134
MICRO-X 100CP
K
88
3431
RAYMAX 2100 MODELS 2130 & 2136
K
88
3154
SELDIX 325 TWO PULSE GENERATOR/CONTROL
K
88
3081
RADKOR, XG-515
K
88
1696
RADKOR XG-325
K
88
0525
3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF
K
88
1886
MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L
K
88
1387
X-RAY GENERATING SYSTEM, TF 800
K
88
1386
X-RAY GENERATING SYSTEM TF 1000
K
88
1795
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K
K
88
0519
SINGLE PHASE DIAG. X-RAY GENERATOR MICRO-X 650
K
88
0522
THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80
K
88
0521
SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-650
K
88
0524
THREE PHASE DIAGNOSTIC X-RAY GENERATOR MICRO-X 100
K
88
0523
THREE PHASE, DIAGNOSTIC GENERATOR MICRO-X 75
K
88
0532
SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX 350
K
87
4946
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60
K
88
0050
EDEC 60R
K
87
5341
EDEC 60 R/F
K
87
5342
EDEC 90C
K
87
3544
MPG-50 X-RAY GENERATOR
K
87
2445
POWER-AID INDEPENDENT X-RAY POWER SOURCE
K
86
4624
PROBE, UPTAKE, NUCLEAR
K
87
2357
TRANSWORLD 360V, MODEL A1-4040
K
87
1145
EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR
K
87
0851
EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR
K
86
4339
PORTA RAY MODEL 325
K
86
2800
SMX GENERATOR
K
86
2682
MVP GENERATOR, CATALOG NO. H8018
K
85
4499
GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR
K
86
0736
FISCHER IMAGING FX325R X-RAY GENERATOR
K
86
0203
TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR
K
85
2908
EDEC 2000
K
85
1011
HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR
K
85
0823
SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR
K
85
0117
XMA 325 (X-RAY GENERATOR)
K
84
3443
EDEC-100
K
84
2348
SPX GENERATOR
K
83
3846
PROCESS 100 ST
K
82
0593
ESP SERIES (X-RAY GENERATORS
K
82
0307
TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE
K
82
0112
SIEMENS POLYDOROS 800
K
81
3051
COMPTAR III
K
81
2616
POLYPHOS 500
K
81
1198
ECCO GENERATOR
K
80
2996
VECTOR-100 X-RAY GENERATOR
K
80
2941
CINESCOPE III RADIOGRAPHIC GENERATOR
K
80
2548
GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80
K
80
2551
GENERATOR, HIGH VOLT, X-RAY, MPX100/125
K
80
2550
GENERATOR, HIGH VOLT, X-RAY, MPX 125
K
80
2549
GENERATOR, HIGH VOLT, X-RAY, MPX 100
K
80
1808
BR 2002 X-RAY GENERATOR SYSTEM
K
80
1408
CINESCOPE III
K
79
2393
GIGANTOS 1012 MP
K
79
2392
POLYPHOS
K
79
1933
CONVERSION CONTRACTOR TIMER KIT
K
79
1214
TRIDOROS 712
K
78
0742
INTRAORAL DENTAL X-RAY GENERATOR
K
77
1294
X-RAY GENERATOR MODEL KXO-15
K
77
1295
X-RAY GENERATOR MODEL KX0-825
K
77
0338
X-RAY CONTROL & X-RAY HV GENERATOR
K
77
0007
MPX 100
K
77
0008
MPX 125
K
77
0006
MPX 80
K
76
0569
THREE PHASE X-RAY CONTROLS & HV GENERATORS
K
76
0568
SINGLE PHASE X-RAY CONTROLS & HV GENERATORS
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
/
IZO
/
K902106
View Source
VPW 2877D5, X-RAY POWER SUPPLY
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K902106
510(k) Type
Traditional
Applicant
VARIAN ASSOC., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/10/1990
Days to Decision
94 days