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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
PGY
Display, Diagnostic Radiology
2
Product Code
K
24
3031
LCD Monitors C310S, G310S, C316S, G316S, C616W
2
Cleared 510(K)
K
24
2008
Coronis OneLook
2
Cleared 510(K)
K
24
1105
3MP Color LCD Monitor (CL-S301)
2
Cleared 510(K)
K
24
1441
RadiForce RX670; RadiForce RX670-AR
2
Cleared 510(K)
K
24
1499
21.3” 5MP Color LCD Display UMD5-21B01
2
Cleared 510(K)
K
23
3336
21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)
2
Cleared 510(K)
K
24
0310
LCD Monitors C310S, G310S, C316S, G316S, C616W
2
Cleared 510(K)
K
24
0130
Medical Monitor (21HQ613D)
2
Cleared 510(K)
K
23
3897
5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)
2
Cleared 510(K)
K
23
3465
RadiForce MX317W
2
Cleared 510(K)
K
23
3693
Nio Color 8MP (MDNC-8132)
2
Cleared 510(K)
K
23
2985
24HR513C
2
Cleared 510(K)
K
23
1026
12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)
2
Cleared 510(K)
K
23
2127
21HQ513D, 32HL512D, 31HN713D, 32HQ713D
2
Cleared 510(K)
K
23
0728
JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor
2
Cleared 510(K)
K
23
1170
C350/C350G LCD Monitor; M550/M550G LCD Monitor
2
Cleared 510(K)
K
23
0723
C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
2
Cleared 510(K)
K
23
0684
RadiForce MX217
2
Cleared 510(K)
K
22
2719
CX50N
2
Cleared 510(K)
K
22
2716
MX50N
2
Cleared 510(K)
K
23
0643
CP620G LCD monitor, CP620 LCD monitor
2
Cleared 510(K)
K
23
0845
32HL512D, 31HN713D, 32HQ713D
2
Cleared 510(K)
K
22
3768
RadiForce RX270
2
Cleared 510(K)
K
23
0520
Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)
2
Cleared 510(K)
K
22
3423
32HQ713D
2
Cleared 510(K)
K
22
3789
21HQ513D
2
Cleared 510(K)
K
22
2864
8MP Color LCD Monitor CL-R813
2
Cleared 510(K)
K
22
2208
Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
2
Cleared 510(K)
K
22
2132
Hisense LCD monitor HMD2G21S, HMD3G21S
2
Cleared 510(K)
K
22
2717
CL24N
2
Cleared 510(K)
K
22
2722
CW60N
2
Cleared 510(K)
K
22
2121
C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor
2
Cleared 510(K)
K
22
1567
LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
2
Cleared 510(K)
K
22
1061
21HQ613D
2
Cleared 510(K)
K
22
1136
RadiForce MX243W
2
Cleared 510(K)
K
21
2231
C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor
2
Cleared 510(K)
K
21
2985
6MP Color LCD Monitor CL-S600
2
Cleared 510(K)
K
21
2295
21HQ513D
2
Cleared 510(K)
K
21
1491
RadiForce RX370
2
Cleared 510(K)
K
20
3733
12MP Color Digital Mammography LCD Monitor CL-S1200
2
Cleared 510(K)
K
21
0345
2MP Monochrome LCD Monitor MS-S200
2
Cleared 510(K)
K
21
0493
CX30N (CX30PQX)
2
Cleared 510(K)
K
21
0491
CW120N
2
Cleared 510(K)
K
20
3106
Nio Fusion 12MP (MDNC-12130)
2
Cleared 510(K)
K
20
2374
4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+
2
Cleared 510(K)
K
20
1777
31HN713D
2
Cleared 510(K)
K
20
1211
3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+
2
Cleared 510(K)
K
20
0742
JUSHA-CP610 LCD Monitor
2
Cleared 510(K)
K
20
1599
2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+
2
Cleared 510(K)
K
20
0889
iMac 27 & PL 4.0
2
Cleared 510(K)
K
20
0864
5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+
2
Cleared 510(K)
K
20
0485
RadiForce RX1270, RadiForce RX1270-AR
2
Cleared 510(K)
K
19
1705
OptikView GUP2103CMI
2
Cleared 510(K)
K
19
2925
32HL512D
2
Cleared 510(K)
K
20
0161
3MP Monochrome Digital Mammography LCD Monitor MS-S300
2
Cleared 510(K)
K
19
1864
21HK512D
2
Cleared 510(K)
K
19
1845
Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
2
Cleared 510(K)
K
19
1137
5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
2
Cleared 510(K)
K
19
0848
JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
2
Cleared 510(K)
K
18
3496
JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor
2
Cleared 510(K)
K
18
3494
R190/R191 LCD Monitor
2
Cleared 510(K)
K
18
3492
JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor
2
Cleared 510(K)
K
19
0153
RadiForce MX216
2
Cleared 510(K)
K
18
3498
JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor
2
Cleared 510(K)
K
18
3499
JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor
2
Cleared 510(K)
K
18
3497
JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor
2
Cleared 510(K)
K
18
2291
6MP Color LCD Monitor (C61W+)
2
Cleared 510(K)
K
18
2591
RadiForce RX360, RX360-AR
2
Cleared 510(K)
K
18
2539
2MP Color LCD Monitor CL-R211
2
Cleared 510(K)
K
18
1609
RadiForce GX560, GX560-AR
2
Cleared 510(K)
K
18
0961
RadiForce MX194
2
Cleared 510(K)
K
17
3434
2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300
2
Cleared 510(K)
K
17
2738
RadiForce RX560, RX560-AR
2
Cleared 510(K)
K
17
2815
2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)
2
Cleared 510(K)
K
17
1812
Nio Color 2MP (MDNC-2123)
2
Cleared 510(K)
K
17
1229
DELL UP3017 with QUBYX PerfectLum bundle
2
Cleared 510(K)
K
17
0944
LCD Monitor (MD310C, MD310G, MD210G)
2
Cleared 510(K)
K
17
0949
RadiForce MX315W
2
Cleared 510(K)
K
17
0837
Nio Color 3MP (MDNC-3421)
2
Cleared 510(K)
K
17
0781
MX50N(MX50YQS)
2
Cleared 510(K)
K
17
0783
CX50N(CX50YQS)
2
Cleared 510(K)
K
17
0476
Nio Color 5.8MP (MDNC-6121)
2
Cleared 510(K)
K
16
3335
6MP Color LCD Monitor, RadiForce RX660, RX660-AR
2
Cleared 510(K)
K
16
2527
8MP Color LCD Monitor (C81W+)
2
Cleared 510(K)
K
16
2497
5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR
2
Cleared 510(K)
K
16
1895
2MP Color LCD Monitor CCL214 (CL21214)
2
Cleared 510(K)
K
16
2196
Dell UP3216Q with QUBYX PerfectLum bundle
2
Cleared 510(K)
K
16
1229
Mammo Tomosynthesis (MDMG-5221)
2
Cleared 510(K)
K
16
1057
Diagnostic Imaging Color LCD Monitor
2
Cleared 510(K)
K
16
0354
MX50T(MX50TQS)
2
Cleared 510(K)
K
16
0353
MX50N(MX50YQS)
2
Cleared 510(K)
K
16
0348
CX30N (CX30PQX)
2
Cleared 510(K)
K
16
0346
MX30N(MX30TQS)
2
Cleared 510(K)
K
16
0355
CX20N(CX20PUX)
2
Cleared 510(K)
K
16
0351
CX50N, CX50YQS
2
Cleared 510(K)
K
16
0347
Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
2
Cleared 510(K)
K
16
0328
DIVA ZSP2105CMI with QUBYX PerfectLum bundle
2
Cleared 510(K)
K
16
0326
5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
2
Cleared 510(K)
K
16
0247
2MP Color LCD Monitor, RadiForce RX250 and RX250-AR
2
Cleared 510(K)
K
15
3354
3MP Color LCD Monitor, RadiForce RX350
2
Cleared 510(K)
K
15
2713
8MP Color LCD Monitor, RadiForce RX850, RX850-AR
2
Cleared 510(K)
K
15
2847
DIVA ZSP5812CMI with QUBYX PerfectLum bundle
2
Cleared 510(K)
K
15
2030
Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
2
Cleared 510(K)
K
15
1972
JUSHA-C43 LCD Monitor
2
Cleared 510(K)
K
15
1861
JUSHA-C23C LCD Monitor
2
Cleared 510(K)
K
15
1883
5MP Monochrome LCD Monitor, RadiForce GX540
2
Cleared 510(K)
K
15
1505
Coronis Uniti
2
Cleared 510(K)
K
15
1238
JUSHA-M23C LCD Monitor
2
Cleared 510(K)
K
15
1134
21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)
2
Cleared 510(K)
K
15
1007
21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)
2
Cleared 510(K)
K
15
0842
JUSHA-M53 Medical Display
2
Cleared 510(K)
K
15
0746
JUSHA-M52C Medical Display
2
Cleared 510(K)
K
15
0821
MDNG-3220 (Nio 3MP LED)
2
Cleared 510(K)
K
15
0106
2MP Color LCD Monitor, RadiForce RS240
2
Cleared 510(K)
K
15
0145
MD322C8 31.5 Diagnostic Imaging LCD Monitor
2
Cleared 510(K)
K
14
3718
Mammography Color Display DP-M3010
2
Cleared 510(K)
K
14
2951
MD210C3 21.3 Diagnostic Imaging LCD Monitor
2
Cleared 510(K)
K
14
3261
2.3MP Color LCD Monitor, RadiForce MX242W
2
Cleared 510(K)
K
14
3098
3MP Color LCD monitor, RadiForce RS340
2
Cleared 510(K)
K
14
3157
Coronis Fusion 4MP LED
2
Cleared 510(K)
K
14
3076
20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)
2
Cleared 510(K)
K
14
2540
24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)
2
Cleared 510(K)
K
14
2536
21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)
2
Cleared 510(K)
K
14
1891
MEDICAL LCD MONITOR
2
Cleared 510(K)
K
14
1690
JUSHA-M33C LCD MONITOR
2
Cleared 510(K)
K
14
1684
JUSHA-C33C LCD MONITOR
2
Cleared 510(K)
K
14
1679
JUSHA-C61 LCD MONITOR
2
Cleared 510(K)
K
13
1601
DELL U3014 WITH QUBYX PERFECTLUM BUNDLE
2
Cleared 510(K)
K
14
1428
MDMC-12133
2
Cleared 510(K)
K
14
0702
8MP COLOR LCD MONITOR, RADIFORCE RX850
2
Cleared 510(K)
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
/
PGY
/
K143076
View Source
20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K143076
510(k) Type
Traditional
Applicant
JVC KENWOOD CORPORATION
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
11/12/2014
Days to Decision
16 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
PGY
Display, Diagnostic Radiology
K
24
3031
LCD Monitors C310S, G310S, C316S, G316S, C616W
K
24
2008
Coronis OneLook
K
24
1105
3MP Color LCD Monitor (CL-S301)
K
24
1441
RadiForce RX670; RadiForce RX670-AR
K
24
1499
21.3” 5MP Color LCD Display UMD5-21B01
K
23
3336
21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)
K
24
0310
LCD Monitors C310S, G310S, C316S, G316S, C616W
K
24
0130
Medical Monitor (21HQ613D)
K
23
3897
5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)
K
23
3465
RadiForce MX317W
K
23
3693
Nio Color 8MP (MDNC-8132)
K
23
2985
24HR513C
K
23
1026
12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)
K
23
2127
21HQ513D, 32HL512D, 31HN713D, 32HQ713D
K
23
0728
JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor
K
23
1170
C350/C350G LCD Monitor; M550/M550G LCD Monitor
K
23
0723
C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
K
23
0684
RadiForce MX217
K
22
2719
CX50N
K
22
2716
MX50N
K
23
0643
CP620G LCD monitor, CP620 LCD monitor
K
23
0845
32HL512D, 31HN713D, 32HQ713D
K
22
3768
RadiForce RX270
K
23
0520
Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)
K
22
3423
32HQ713D
K
22
3789
21HQ513D
K
22
2864
8MP Color LCD Monitor CL-R813
K
22
2208
Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
K
22
2132
Hisense LCD monitor HMD2G21S, HMD3G21S
K
22
2717
CL24N
K
22
2722
CW60N
K
22
2121
C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor
K
22
1567
LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
K
22
1061
21HQ613D
K
22
1136
RadiForce MX243W
K
21
2231
C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor
K
21
2985
6MP Color LCD Monitor CL-S600
K
21
2295
21HQ513D
K
21
1491
RadiForce RX370
K
20
3733
12MP Color Digital Mammography LCD Monitor CL-S1200
K
21
0345
2MP Monochrome LCD Monitor MS-S200
K
21
0493
CX30N (CX30PQX)
K
21
0491
CW120N
K
20
3106
Nio Fusion 12MP (MDNC-12130)
K
20
2374
4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+
K
20
1777
31HN713D
K
20
1211
3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+
K
20
0742
JUSHA-CP610 LCD Monitor
K
20
1599
2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+
K
20
0889
iMac 27 & PL 4.0
K
20
0864
5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+
K
20
0485
RadiForce RX1270, RadiForce RX1270-AR
K
19
1705
OptikView GUP2103CMI
K
19
2925
32HL512D
K
20
0161
3MP Monochrome Digital Mammography LCD Monitor MS-S300
K
19
1864
21HK512D
K
19
1845
Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
K
19
1137
5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
K
19
0848
JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
K
18
3496
JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor
K
18
3494
R190/R191 LCD Monitor
K
18
3492
JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor
K
19
0153
RadiForce MX216
K
18
3498
JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor
K
18
3499
JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor
K
18
3497
JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor
K
18
2291
6MP Color LCD Monitor (C61W+)
K
18
2591
RadiForce RX360, RX360-AR
K
18
2539
2MP Color LCD Monitor CL-R211
K
18
1609
RadiForce GX560, GX560-AR
K
18
0961
RadiForce MX194
K
17
3434
2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300
K
17
2738
RadiForce RX560, RX560-AR
K
17
2815
2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)
K
17
1812
Nio Color 2MP (MDNC-2123)
K
17
1229
DELL UP3017 with QUBYX PerfectLum bundle
K
17
0944
LCD Monitor (MD310C, MD310G, MD210G)
K
17
0949
RadiForce MX315W
K
17
0837
Nio Color 3MP (MDNC-3421)
K
17
0781
MX50N(MX50YQS)
K
17
0783
CX50N(CX50YQS)
K
17
0476
Nio Color 5.8MP (MDNC-6121)
K
16
3335
6MP Color LCD Monitor, RadiForce RX660, RX660-AR
K
16
2527
8MP Color LCD Monitor (C81W+)
K
16
2497
5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR
K
16
1895
2MP Color LCD Monitor CCL214 (CL21214)
K
16
2196
Dell UP3216Q with QUBYX PerfectLum bundle
K
16
1229
Mammo Tomosynthesis (MDMG-5221)
K
16
1057
Diagnostic Imaging Color LCD Monitor
K
16
0354
MX50T(MX50TQS)
K
16
0353
MX50N(MX50YQS)
K
16
0348
CX30N (CX30PQX)
K
16
0346
MX30N(MX30TQS)
K
16
0355
CX20N(CX20PUX)
K
16
0351
CX50N, CX50YQS
K
16
0347
Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
K
16
0328
DIVA ZSP2105CMI with QUBYX PerfectLum bundle
K
16
0326
5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
K
16
0247
2MP Color LCD Monitor, RadiForce RX250 and RX250-AR
K
15
3354
3MP Color LCD Monitor, RadiForce RX350
K
15
2713
8MP Color LCD Monitor, RadiForce RX850, RX850-AR
K
15
2847
DIVA ZSP5812CMI with QUBYX PerfectLum bundle
K
15
2030
Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
K
15
1972
JUSHA-C43 LCD Monitor
K
15
1861
JUSHA-C23C LCD Monitor
K
15
1883
5MP Monochrome LCD Monitor, RadiForce GX540
K
15
1505
Coronis Uniti
K
15
1238
JUSHA-M23C LCD Monitor
K
15
1134
21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)
K
15
1007
21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)
K
15
0842
JUSHA-M53 Medical Display
K
15
0746
JUSHA-M52C Medical Display
K
15
0821
MDNG-3220 (Nio 3MP LED)
K
15
0106
2MP Color LCD Monitor, RadiForce RS240
K
15
0145
MD322C8 31.5 Diagnostic Imaging LCD Monitor
K
14
3718
Mammography Color Display DP-M3010
K
14
2951
MD210C3 21.3 Diagnostic Imaging LCD Monitor
K
14
3261
2.3MP Color LCD Monitor, RadiForce MX242W
K
14
3098
3MP Color LCD monitor, RadiForce RS340
K
14
3157
Coronis Fusion 4MP LED
K
14
3076
20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)
K
14
2540
24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)
K
14
2536
21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)
K
14
1891
MEDICAL LCD MONITOR
K
14
1690
JUSHA-M33C LCD MONITOR
K
14
1684
JUSHA-C33C LCD MONITOR
K
14
1679
JUSHA-C61 LCD MONITOR
K
13
1601
DELL U3014 WITH QUBYX PERFECTLUM BUNDLE
K
14
1428
MDMC-12133
K
14
0702
8MP COLOR LCD MONITOR, RADIFORCE RX850
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
/
PGY
/
K143076
View Source
20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K143076
510(k) Type
Traditional
Applicant
JVC KENWOOD CORPORATION
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
11/12/2014
Days to Decision
16 days
Submission Type
Summary