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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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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
K
24
1495
Jazz Classic
2
Cleared 510(K)
K
24
2329
CT Collaboration Live
2
Cleared 510(K)
K
24
2062
1CMR Pro
2
Cleared 510(K)
K
24
1981
Change Healthcare Stratus Imaging PACS
2
Cleared 510(K)
K
24
2709
JLK-PWI
2
Cleared 510(K)
K
24
1223
eRAD PACS
2
Cleared 510(K)
K
24
2512
ROCC Console
2
Cleared 510(K)
K
24
3012
MIM – Symphony HDR Fusion
2
Cleared 510(K)
K
24
3209
nordicMEDiVA
2
Cleared 510(K)
K
24
2556
JLK-CTP
2
Cleared 510(K)
K
24
0385
VINT
2
Cleared 510(K)
K
24
1569
syngo Application Software
2
Cleared 510(K)
K
24
0243
EConsole2
2
Cleared 510(K)
K
24
1524
Elucid PlaqueIQ
2
Cleared 510(K)
K
23
3998
TRAQinform IQ
2
Cleared 510(K)
K
24
1302
SonoSync
2
Cleared 510(K)
K
24
0290
AiMIFY (1.x)
2
Cleared 510(K)
K
24
1094
Bullsai
2
Cleared 510(K)
K
24
0724
SynthVISION 1.0.0
2
Cleared 510(K)
K
23
3761
Orthopaedic Surgery Planning Software (AIJOINT)
2
Cleared 510(K)
K
24
1114
EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)
2
Cleared 510(K)
K
24
1879
vRad Viewer
2
Cleared 510(K)
K
24
1121
MICSI-RMT
2
Cleared 510(K)
K
24
0705
Vitrea Software Package, VSTP-002A V2.0
2
Cleared 510(K)
K
24
1300
ViewPoint 6
2
Cleared 510(K)
K
23
3908
cNeuro cDAT
2
Cleared 510(K)
K
24
1608
nordicMEDiVA
2
Cleared 510(K)
K
23
3331
MediOMx
2
Cleared 510(K)
K
24
0281
Bone Suppression Software
2
Cleared 510(K)
K
22
3427
Mimics Enlight CMF
2
Cleared 510(K)
K
24
0294
Syngo Carbon Enterprise Access (VA40A)
2
Cleared 510(K)
K
23
2759
Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
2
Cleared 510(K)
K
23
3620
MIM - Centiloid Scaling
2
Cleared 510(K)
K
23
2862
MIM – Monte Carlo Dosimetry
2
Cleared 510(K)
K
23
2976
VUZE System
2
Cleared 510(K)
K
23
2514
MIM – Dose Analysis
2
Cleared 510(K)
K
23
3699
SubtleREFORMAT (1.x)
2
Cleared 510(K)
K
24
0839
OpenRad Cloud
2
Cleared 510(K)
K
24
0822
Image Management V15
2
Cleared 510(K)
K
23
3582
Rapid
2
Cleared 510(K)
K
23
2641
Neorad Pacs (Neorad Pacs)
2
Cleared 510(K)
K
23
2891
CARPL (CARPL)
2
Cleared 510(K)
K
24
0620
Cube Navigator
2
Cleared 510(K)
K
23
3660
nCommand Lite System
2
Cleared 510(K)
K
23
3599
X-Clever (ASHK100G)
2
Cleared 510(K)
K
23
3930
MRCP+ version 2 (MRCP+ v2)
2
Cleared 510(K)
K
23
3572
Autofuse
2
Cleared 510(K)
K
23
3217
Mimics Cardiac Planner
2
Cleared 510(K)
K
23
1662
Aid-U
2
Cleared 510(K)
K
23
2339
Augmented Reality Application
2
Cleared 510(K)
K
23
2007
CAAS MR Solutions
2
Cleared 510(K)
K
23
1396
CEPHX- Cephalometric Analysis Software
2
Cleared 510(K)
K
23
3714
BreView
2
Cleared 510(K)
K
23
1607
Axial3D Cloud Segmentation Service
2
Cleared 510(K)
K
23
3226
FlexView Diagnostic (v1.1.20)
2
Cleared 510(K)
K
23
2589
Horos MD™
2
Cleared 510(K)
K
23
2744
syngo Virtual Cockpit (VB10A)
2
Cleared 510(K)
K
23
3176
uOmnispace.MI
2
Cleared 510(K)
K
23
0955
syngo Application Software
2
Cleared 510(K)
K
23
1570
StrokeViewer Perfusion
2
Cleared 510(K)
K
23
3634
TeleScan
2
Cleared 510(K)
K
23
1898
DTX Studio Clinic (4.0)
2
Cleared 510(K)
K
22
3757
Bonelogic
2
Cleared 510(K)
K
23
2661
Myocardial Strain Software Application
2
Cleared 510(K)
K
23
1498
TraumaCad Neo
2
Cleared 510(K)
K
23
0856
BrainSpec Core™ Software
2
Cleared 510(K)
K
23
0854
SwiftMR
2
Cleared 510(K)
K
23
2086
spineEOS
2
Cleared 510(K)
K
22
3909
R2GATE Lite TM
2
Cleared 510(K)
K
23
1225
EConsole1
2
Cleared 510(K)
K
23
0249
Ikshana
2
Cleared 510(K)
K
23
1642
Veuron-Brain-pAb3
2
Cleared 510(K)
K
23
0252
OFIX MIS App
2
Cleared 510(K)
K
22
3659
Jazz
2
Cleared 510(K)
K
23
1385
Rology Teleradiology Platform (v.1.22.1103)
2
Cleared 510(K)
K
23
2189
OrionXR
2
Cleared 510(K)
K
23
1353
AccuCTP Pro
2
Cleared 510(K)
K
22
0034
NEUROShield
2
Cleared 510(K)
K
23
1047
UniSyn Molecular Imaging (6-3-1)
2
Cleared 510(K)
K
23
1656
Brainomix 360 e-MRI
2
Cleared 510(K)
K
22
3180
AIRAscore
2
Cleared 510(K)
K
23
1503
CUPTIMIZE™ Advanced
2
Cleared 510(K)
K
22
3660
SaintView
2
Cleared 510(K)
K
23
2100
Efai Pacs Picture Archiving and Communication System Pro
2
Cleared 510(K)
K
23
0540
Patient Specific Planning Solution™ 3D Bone Models
2
Cleared 510(K)
K
22
3322
Argus Cognitive ReVISION Software
2
Cleared 510(K)
K
22
2683
Fibroid Mapping Reviewer Application (FMRA)
2
Cleared 510(K)
K
23
1041
JiveX (Model Number / Release: 5.4)
2
Cleared 510(K)
K
23
0016
Cercare Medical Neurosuite
2
Cleared 510(K)
K
22
3290
CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)
2
Cleared 510(K)
K
23
1351
Chondral Quant
2
Cleared 510(K)
K
22
3125
XR90 (XR90-SYS)
2
Cleared 510(K)
K
21
3253
Pixyl.Neuro
2
Cleared 510(K)
K
22
3048
Medisystem Pacs
2
Cleared 510(K)
K
22
3091
CT Perfusion V1.0
2
Cleared 510(K)
K
23
1360
Ambra PACS
2
Cleared 510(K)
K
22
3532
Olea S.I.A. Neurovascular V1.0
2
Cleared 510(K)
K
22
3555
Brainomix 360 e-CTP
2
Cleared 510(K)
K
22
3841
KBA3D
2
Cleared 510(K)
K
22
2359
Quicktome Software Suite
2
Cleared 510(K)
K
23
0044
Pre-Sure
2
Cleared 510(K)
K
22
2035
Avatar Medical Software V1
2
Cleared 510(K)
K
23
1162
ROSA Hip System
2
Cleared 510(K)
K
23
0803
ADAS 3D
2
Cleared 510(K)
K
21
2758
Autoplaque
2
Cleared 510(K)
K
22
2854
iTFlow
2
Cleared 510(K)
K
22
3623
SubtleMR (2.3.x)
2
Cleared 510(K)
K
22
2987
Akunah REFLECT
2
Cleared 510(K)
K
22
0437
Neurophet AQUA
2
Cleared 510(K)
K
23
0119
3D Anatomic Model
2
Cleared 510(K)
K
22
1870
CarnaLife Holo
2
Cleared 510(K)
K
23
0552
MR DWI/FLAIR Measurement V1.0
2
Cleared 510(K)
K
23
0906
Konicaminolta DI-X1
2
Cleared 510(K)
K
23
0468
EzDent Web
2
Cleared 510(K)
K
23
0772
Quantib Prostate
2
Cleared 510(K)
K
23
0393
UniCam Evo Software
2
Cleared 510(K)
K
23
0264
Ezra Flash
2
Cleared 510(K)
K
22
2781
Augmento
2
Cleared 510(K)
K
23
0575
Limbus Contour
2
Cleared 510(K)
K
21
3660
RadAlly
2
Cleared 510(K)
K
21
1059
CereFlow V1.2
2
Cleared 510(K)
K
22
1984
InterView XP; InterView FUSION
2
Cleared 510(K)
K
23
0561
Syngo Carbon Space VA30A
2
Cleared 510(K)
K
22
3490
FlightPlan for Embolization
2
Cleared 510(K)
K
23
0294
CoverScan (CoverScan v1.1)
2
Cleared 510(K)
K
22
2975
Advantis Platform
2
Cleared 510(K)
K
22
1680
Xeleris V Processing and Review System
2
Cleared 510(K)
K
22
2757
Clarus Viewer
2
Cleared 510(K)
K
21
3891
RealNow
2
Cleared 510(K)
K
22
3820
EzDent-i / E2 / Prora View/ Smart M Viewer
2
Cleared 510(K)
K
23
0196
syngo.via View&GO VA40A
2
Cleared 510(K)
K
22
3425
MD.ai Viewer
2
Cleared 510(K)
K
23
0012
Atomica Planner
2
Cleared 510(K)
K
22
1725
Advanced MyHip Planner
2
Cleared 510(K)
K
22
1627
PerfusionGo Plus
2
Cleared 510(K)
K
22
2593
TruPlan Computed Tomography (CT) Imaging Software
2
Cleared 510(K)
K
22
3800
MIM – Additional Tracers
2
Cleared 510(K)
K
22
0649
Elucis
2
Cleared 510(K)
K
22
3502
MR Diffusion Perfusion Mismatch V1.0
2
Cleared 510(K)
K
22
3363
MAMMOVISTA B.smart (VB70)
2
Cleared 510(K)
K
22
2458
AIBOLIT 3D+
2
Cleared 510(K)
K
22
3336
Vitrea Software Package, VSTP-002A
2
Cleared 510(K)
K
22
2577
TECHFIT Diagnostic Models
2
Cleared 510(K)
K
21
3263
OnyxCeph
2
Cleared 510(K)
K
22
2767
PeekMed web (v1)
2
Cleared 510(K)
K
22
2195
aprevo® Digital Workflow
2
Cleared 510(K)
K
22
1796
Cyware 4H and Cysart 4H
2
Cleared 510(K)
K
22
3071
Xenoview VDP
2
Cleared 510(K)
K
22
2320
MedDream
2
Cleared 510(K)
K
22
0630
TorchTM Software
2
Cleared 510(K)
K
21
3215
VSI HoloMedicine
2
Cleared 510(K)
K
22
3152
Vision 2, EVARVision, TrackVision 2, HeartVision 2
2
Cleared 510(K)
K
22
2054
Denti.AI Auto-Chart
2
Cleared 510(K)
K
22
1499
Minimally Invasive Prostate Surgery Navigation System
2
Cleared 510(K)
K
22
0663
AccuCTP
2
Cleared 510(K)
K
22
2476
OmegaAI Image Viewer
2
Cleared 510(K)
K
22
1677
Synapse 3D Base Tools v6.6
2
Cleared 510(K)
K
22
1478
Dolphin Blue Imaging
2
Cleared 510(K)
K
22
2470
3Dicom MD
2
Cleared 510(K)
K
21
3128
IntraOp VSP Software Device
2
Cleared 510(K)
K
22
2662
Vitrea CT Cardiac Analysis
2
Cleared 510(K)
K
22
1501
syngo.via View&GO
2
Cleared 510(K)
K
22
0758
e-Ortho Shoulder Software v1.1
2
Cleared 510(K)
K
22
2069
Ez3D-i/E3
2
Cleared 510(K)
K
21
3520
AXIR-CX
2
Cleared 510(K)
K
22
0903
WebCeph
2
Cleared 510(K)
K
22
0433
syngo Application Software (VE21)
2
Cleared 510(K)
K
22
2145
EzDent-i / E2 / Prora View/ Smart M Viewer
2
Cleared 510(K)
K
22
0349
TeraRecon Neuro
2
Cleared 510(K)
K
22
2072
Dolphin Imaging 12.0
2
Cleared 510(K)
K
22
1405
Neurophet SCALE PET
2
Cleared 510(K)
K
22
0733
OptiVu ROSA MxR
2
Cleared 510(K)
K
22
0624
AI4CMR v1.0
2
Cleared 510(K)
K
21
3922
FX SPS
2
Cleared 510(K)
K
22
0039
AutoSeg
2
Cleared 510(K)
K
22
1426
Functional MR V1.0
2
Cleared 510(K)
K
22
1511
Axial3D Cloud Segmentation Service
2
Cleared 510(K)
K
21
3665
Syngo Carbon Space VA20A
2
Cleared 510(K)
K
22
1463
ElucidVivo A.3
2
Cleared 510(K)
K
21
3684
SurgiCase Viewer
2
Cleared 510(K)
K
22
1065
MediLab
2
Cleared 510(K)
K
22
0205
3D Anatomic Models
2
Cleared 510(K)
K
22
1270
EchoNavigator R4.0
2
Cleared 510(K)
K
22
0416
SwiftMR
2
Cleared 510(K)
K
22
1000
ON3D
2
Cleared 510(K)
K
22
0832
syngo Dynamics (Version VA40E)
2
Cleared 510(K)
K
21
2565
CoverScan v1
2
Cleared 510(K)
K
21
2376
Caas Qardia
2
Cleared 510(K)
K
22
1106
Quantib Prostate
2
Cleared 510(K)
K
22
0727
inHEART MODELS
2
Cleared 510(K)
K
21
3975
KEOPS Balance Analyzer 3D
2
Cleared 510(K)
K
21
1966
Segment 3DPrint
2
Cleared 510(K)
K
21
3302
exoplan
2
Cleared 510(K)
K
22
0684
Oryx Cloud Imaging
2
Cleared 510(K)
K
22
0590
aPROMISE X
2
Cleared 510(K)
K
21
1713
AngioCloud Service
2
Cleared 510(K)
K
21
2981
MirrorMe3D Modeling System
2
Cleared 510(K)
K
22
0779
XD
2
Cleared 510(K)
K
22
0767
TeleScan
2
Cleared 510(K)
K
20
3783
ClariPulmo
2
Cleared 510(K)
K
21
3562
DTX Studio Clinic 3.0
2
Cleared 510(K)
K
21
2040
RI.HIP MODELER
2
Cleared 510(K)
K
21
2720
nordicDSC
2
Cleared 510(K)
K
22
0003
EzOrtho v1.3
2
Cleared 510(K)
K
21
3165
Rapid
2
Cleared 510(K)
K
21
3801
Veuron-Brain-pAb2
2
Cleared 510(K)
K
21
3737
Quantib ND
2
Cleared 510(K)
K
21
2005
UNiD Spine Analyzer
2
Cleared 510(K)
K
21
1443
AIBOLIT 3D+
2
Cleared 510(K)
K
21
0830
VUZE System
2
Cleared 510(K)
K
21
1156
CONVIVO In Vivo Pathology Suite
2
Cleared 510(K)
K
21
3140
Claritas iPET
2
Cleared 510(K)
K
21
0931
Libby IAAA v1.0
2
Cleared 510(K)
K
21
2420
Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio
2
Cleared 510(K)
K
21
1114
Will3D
2
Cleared 510(K)
K
21
1039
BIT-Motion
2
Cleared 510(K)
K
21
2137
X-Clever
2
Cleared 510(K)
K
20
3743
EXA
2
Cleared 510(K)
K
21
0916
PVmed Contouring Software
2
Cleared 510(K)
K
21
0241
ImplaStation
2
Cleared 510(K)
K
21
1432
Myomics Q
2
Cleared 510(K)
K
21
2984
MiPACS HTML5 Web Viewer
2
Cleared 510(K)
K
21
2621
MAMMOVISTA B.smart
2
Cleared 510(K)
K
21
1876
Intellijoint VIEW
2
Cleared 510(K)
K
21
2887
RTapp
2
Cleared 510(K)
K
21
0344
inVisionOS
2
Cleared 510(K)
K
21
2550
Hura CTP v1.0
2
Cleared 510(K)
K
21
1356
GIQuant
2
Cleared 510(K)
K
21
2896
Visible Patient Suite
2
Cleared 510(K)
K
21
3326
VisionX 3.0
2
Cleared 510(K)
K
21
1987
ATEC Alignment App
2
Cleared 510(K)
K
21
0807
FlightPlan for Liver
2
Cleared 510(K)
K
21
2470
iRAD
2
Cleared 510(K)
K
21
2528
Change Healthcare Cardiology
2
Cleared 510(K)
K
21
0999
SwiftMR
2
Cleared 510(K)
K
20
2808
Brainance MD
2
Cleared 510(K)
K
21
1429
NAVIPLAN - CT Planning Software for Total Hip Replacement
2
Cleared 510(K)
K
21
1795
EzDent-i/ E2/ Prora View/ Smart M Viewer
2
Cleared 510(K)
K
21
0726
ImmersiveTouch
2
Cleared 510(K)
K
21
1700
EzDent Web
2
Cleared 510(K)
K
21
2777
Collaboration Live
2
Cleared 510(K)
K
21
2321
JiveX (Model Number / Release: 5.3)
2
Cleared 510(K)
K
21
2685
KONICAMINOLTA DI-X1
2
Cleared 510(K)
K
21
1257
EFAI PACS Picture Archiving and Communication System
2
Cleared 510(K)
K
20
2056
Kinepict Medical Imaging Tool 4.0
2
Cleared 510(K)
K
21
2421
ADAS 3D
2
Cleared 510(K)
K
20
3696
RBknee
2
Cleared 510(K)
K
21
1793
EzOrtho
2
Cleared 510(K)
K
21
1791
Ez3D-i/E3
2
Cleared 510(K)
K
21
0998
ROSA Hip System
2
Cleared 510(K)
K
20
1573
Brain Perfusion (BP) application
2
Cleared 510(K)
K
21
2230
TruSPECT Radiological Image Processing Station
2
Cleared 510(K)
K
21
1863
eVolve PACS
2
Cleared 510(K)
K
21
2175
DynaCAD
2
Cleared 510(K)
K
21
2074
ClariCT.AI
2
Cleared 510(K)
K
21
1655
aPROMISE
2
Cleared 510(K)
K
21
1279
Volpara Imaging Software
2
Cleared 510(K)
K
21
1386
MySpine WebPlanner & MyBalance
2
Cleared 510(K)
K
20
3765
ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray
2
Cleared 510(K)
K
21
1480
NubeX
2
Cleared 510(K)
K
20
1835
PRE-SURE
2
Cleared 510(K)
K
21
0653
ONE Planner Hip
2
Cleared 510(K)
K
21
1656
3D Echo v1.1
2
Cleared 510(K)
K
20
2718
Qmenta Care Platform Family
2
Cleared 510(K)
K
20
0704
ZedView
2
Cleared 510(K)
K
21
1312
Universal Viewer
2
Cleared 510(K)
K
21
0257
Xoran Workstation, Model 10050
2
Cleared 510(K)
K
21
0187
Overjet Dental Assist
2
Cleared 510(K)
K
20
2793
Cercare Medical Neurosuite
2
Cleared 510(K)
K
21
0072
HOLOSCOPE-i
2
Cleared 510(K)
K
21
0066
ImagePilot
2
Cleared 510(K)
K
21
0682
SOTA Cloud Imaging
2
Cleared 510(K)
K
20
2521
PtoleMedic System
2
Cleared 510(K)
K
20
2084
DeepLook PRECISE
2
Cleared 510(K)
K
21
0850
ADAS 3D
2
Cleared 510(K)
K
20
3195
Simpleware ScanIP Medical
2
Cleared 510(K)
K
21
0071
SIS System (Version 5.1.0)
2
Cleared 510(K)
K
20
3518
Quicktome
2
Cleared 510(K)
K
20
3651
Cuptimize
2
Cleared 510(K)
K
20
3182
SubtleMR
2
Cleared 510(K)
K
20
2990
NinesMeasure
2
Cleared 510(K)
K
20
2212
TruPlan
2
Cleared 510(K)
K
20
0589
MyPAO Planning Report
2
Cleared 510(K)
K
21
0136
PhantomMSK Hip
2
Cleared 510(K)
K
20
3312
Vitrea Software Package, VSTP-001A
2
Cleared 510(K)
K
20
3103
Synapse 3D, Synapse 3D Base Tools v6.1
2
Cleared 510(K)
K
20
3290
Bonelogic
2
Cleared 510(K)
K
20
3582
QUIBIM Precision Prostate (qp-Prostate)
2
Cleared 510(K)
K
20
3104
IBM iConnect Access
2
Cleared 510(K)
K
20
3677
ViewPoint 6
2
Cleared 510(K)
K
20
3142
Veuron-Brain-pAb
2
Cleared 510(K)
K
20
2847
AccuBrain
2
Cleared 510(K)
K
20
2414
BrainInsight
2
Cleared 510(K)
K
20
2229
AI Metrics
2
Cleared 510(K)
K
20
1250
SQuEEZ Software
2
Cleared 510(K)
K
20
3249
Nucleus.io
2
Cleared 510(K)
K
20
2487
HealthJOINT
2
Cleared 510(K)
K
20
0572
Planmeca Romexis
2
Cleared 510(K)
K
20
3156
DTX Studio Clinic
2
Cleared 510(K)
K
20
2805
Optimized Positioning System (OPS) Insight
2
Cleared 510(K)
K
19
3287
CorInsights MRI
2
Cleared 510(K)
K
20
3287
DBSWIN, VISTAEASY
2
Cleared 510(K)
K
19
3306
PROView
2
Cleared 510(K)
K
20
0750
Neuro.Al Algorithm
2
Cleared 510(K)
K
20
0350
MyHip Planner & Verifier
2
Cleared 510(K)
K
20
3058
CloudVue
2
Cleared 510(K)
K
20
2519
OrthoNext Platform System
2
Cleared 510(K)
K
20
2948
EzOrtho
2
Cleared 510(K)
K
20
1710
A View LCS
2
Cleared 510(K)
K
20
2501
Quantib Prostate
2
Cleared 510(K)
K
20
0810
IPS CaseDesigner
2
Cleared 510(K)
K
20
2292
UDE
2
Cleared 510(K)
K
20
2280
Cleerly Labs v2.0
2
Cleared 510(K)
K
20
1928
e-Ortho Shoulder Software
2
Cleared 510(K)
K
19
2051
THINQ
2
Cleared 510(K)
K
20
1103
Xeleris V Processing and Review Systems
2
Cleared 510(K)
K
20
0603
AAA Model
2
Cleared 510(K)
K
20
0852
EchoPAC Software Only, EchoPAC Plug-In
2
Cleared 510(K)
K
19
2890
SentEP
2
Cleared 510(K)
K
20
1369
AVA (Augmented Vascular Analysis)
2
Cleared 510(K)
K
20
1665
Collaboration Live
2
Cleared 510(K)
K
20
2297
Aline Ablation Intelligence
2
Cleared 510(K)
K
20
2256
3Shape Implant Studio
2
Cleared 510(K)
K
20
1948
AcroDTI Visualizer
2
Cleared 510(K)
K
20
2335
Ambra ProViewer
2
Cleared 510(K)
K
20
0973
Synapse 3D Cardiac Tools
2
Cleared 510(K)
K
20
0714
AVIEW
2
Cleared 510(K)
K
20
2116
EzDent-i/ E2/ Prora View/ Smart M Viewer
2
Cleared 510(K)
K
20
1352
3D Auto LAA
2
Cleared 510(K)
K
20
1632
TOMTEC-ARENA
2
Cleared 510(K)
K
20
1232
Limbus Contour
2
Cleared 510(K)
K
20
0822
Braid
2
Cleared 510(K)
K
20
1465
SuRgical Planner (SRP) BrainStorm
2
Cleared 510(K)
K
20
1365
True 3D Viewer
2
Cleared 510(K)
K
19
3294
AI-Rad Companion Engine
2
Cleared 510(K)
K
20
1296
i-Rapha Solution
2
Cleared 510(K)
K
20
1477
syngo.via View&GO
2
Cleared 510(K)
K
19
3042
Optimized Positioning System (OPS) ReView
2
Cleared 510(K)
K
19
3290
AI-Rad Companion Brain MR
2
Cleared 510(K)
K
20
0899
Quantib AI Node
2
Cleared 510(K)
K
19
2630
uWS-MI
2
Cleared 510(K)
K
20
1202
MI View&GO
2
Cleared 510(K)
K
19
2692
Brainomix 360 e-CTA
2
Cleared 510(K)
K
20
0274
CariCloud
2
Cleared 510(K)
K
20
1062
syngo Ultrasound Apps Suite (sUSAS)
2
Cleared 510(K)
K
20
0546
ZeeroMED View
2
Cleared 510(K)
K
20
0315
Ziostation2
2
Cleared 510(K)
K
19
3220
AVIEW LCS
2
Cleared 510(K)
K
19
2656
Optimized Positioning System (OPS) Insight
2
Cleared 510(K)
K
19
3523
ArthrexVIP Web Portal
2
Cleared 510(K)
K
19
2475
NemoFAB
2
Cleared 510(K)
K
20
0703
JiveX
2
Cleared 510(K)
K
19
3369
Xelis Dental 2.0
2
Cleared 510(K)
K
20
0078
VARO Plan
2
Cleared 510(K)
K
20
0713
EchoNavigator
2
Cleared 510(K)
K
19
2176
IntelePACS
2
Cleared 510(K)
K
19
0767
AnatomicAligner
2
Cleared 510(K)
K
19
2888
EzOrtho
2
Cleared 510(K)
K
19
0993
Kinepict Medical Imaging Tool version v2.2
2
Cleared 510(K)
K
19
2962
icobrain-ctp
2
Cleared 510(K)
K
20
0178
Ez3D-i /E3
2
Cleared 510(K)
K
19
2973
densitas densityai
2
Cleared 510(K)
K
20
0179
Collaboration Live
2
Cleared 510(K)
K
20
0132
Ashvins
2
Cleared 510(K)
K
19
2923
Vitrea Software Package
2
Cleared 510(K)
K
19
2372
ASCEND Image Viewer
2
Cleared 510(K)
K
19
3498
Infinitt RT PACS
2
Cleared 510(K)
K
19
2165
Acteon Imaging Suite
2
Cleared 510(K)
K
19
2462
syngo.MR Applications
2
Cleared 510(K)
K
19
3261
FlightPlan for Embolization
2
Cleared 510(K)
K
19
1014
Elements Viewer
2
Cleared 510(K)
K
19
2098
EzMobile
2
Cleared 510(K)
K
19
1125
ADAS 3D
2
Cleared 510(K)
K
19
2917
ViewPoint 6
2
Cleared 510(K)
K
19
2912
AutoMIStar
2
Cleared 510(K)
K
19
3403
UroNav System
2
Cleared 510(K)
K
19
3149
True 3D Viewer Software
2
Cleared 510(K)
K
19
2629
Spinalytics
2
Cleared 510(K)
K
19
2040
AVIEW Modeler
2
Cleared 510(K)
K
18
3676
DentiqAir
2
Cleared 510(K)
K
19
2531
QyScore Software
2
Cleared 510(K)
K
19
2130
Icobrain
2
Cleared 510(K)
K
19
2571
NemoScan
2
Cleared 510(K)
K
19
2279
PhantomMSK Trauma
2
Cleared 510(K)
K
19
2348
SICAT Implant V2.0
2
Cleared 510(K)
K
19
2038
Emprint Visualization Application
2
Cleared 510(K)
K
19
2508
Medsynapse Ris Pacs & Medsynapse VNA
2
Cleared 510(K)
K
19
1278
RSI-MRI+
2
Cleared 510(K)
K
19
1959
QuantX Breast MRI Biopsy Guidance Plugin
2
Cleared 510(K)
K
19
1026
MEDIP PRO
2
Cleared 510(K)
K
19
2109
KOALA
2
Cleared 510(K)
K
19
0868
Cleerly Labs
2
Cleared 510(K)
K
19
2743
VisionX 2.4
2
Cleared 510(K)
K
18
3412
mediCAD Web
2
Cleared 510(K)
K
19
1544
Synapse 3D Blood Flow Analysis
2
Cleared 510(K)
K
19
2455
Merge PACS
2
Cleared 510(K)
K
19
1216
Voxel Dosimetry™ v1.0
2
Cleared 510(K)
K
19
0162
SmartCeph
2
Cleared 510(K)
K
19
1493
Ventripoint Medical System Plus (VMS+) 3.0
2
Cleared 510(K)
K
19
2200
DynaCAD
2
Cleared 510(K)
K
19
1610
RTapp
2
Cleared 510(K)
K
19
2435
NuVasive NuvaLine
2
Cleared 510(K)
K
19
1530
StoneChecker
2
Cleared 510(K)
K
19
2276
Merge Cardio
2
Cleared 510(K)
K
19
1688
SubtleMR
2
Cleared 510(K)
K
19
2304
SIS Software Version 3.6.0
2
Cleared 510(K)
K
19
0780
syngo Application Software
2
Cleared 510(K)
K
18
3489
D2P
2
Cleared 510(K)
K
18
3544
Efficient Care 3D Planning
2
Cleared 510(K)
K
18
3458
exoplan 2.3
2
Cleared 510(K)
K
19
1262
aBSI
2
Cleared 510(K)
K
18
3193
MREplus+ Software
2
Cleared 510(K)
K
19
1309
syngo.via MI Workflows VB40A, Scenium
2
Cleared 510(K)
K
19
1585
iNtuition-Structural Heart Module
2
Cleared 510(K)
K
19
0694
Unifi Workspace v1.0.0
2
Cleared 510(K)
K
18
2904
syngo.MR Applications
2
Cleared 510(K)
K
19
0096
R2GATE
2
Cleared 510(K)
K
18
3170
uWS-CT
2
Cleared 510(K)
K
19
0913
QLAB Advanced Quantification Software 13
2
Cleared 510(K)
K
18
3460
ClariCT.AI
2
Cleared 510(K)
K
19
0874
Materialise Mimics Enlight
2
Cleared 510(K)
K
19
1188
ASHK100G
2
Cleared 510(K)
K
19
1040
syngo.via (Version VB40A)
2
Cleared 510(K)
K
19
0764
SurgicalAR
2
Cleared 510(K)
K
19
0866
XmaruView V1 (Xmaru Chiroview, Xmaru Podview)
2
Cleared 510(K)
K
19
0042
Brainlab Elements Image Fusion Angio
2
Cleared 510(K)
K
18
3248
Synapse Enterprise Viewer Version 1.0
2
Cleared 510(K)
K
19
0791
Ez3D-i/E3
2
Cleared 510(K)
K
18
3593
Lung Vision System
2
Cleared 510(K)
K
19
0420
NDOHD High Definition Imaging System (NDOHD)
2
Cleared 510(K)
K
18
2572
InstaRISPACS / InstaZFP / InstaMobi v5.0
2
Cleared 510(K)
K
19
0629
DBSWIN and VISTAEASY Imaging Software
2
Cleared 510(K)
K
18
3210
Thoracic VCAR with GSI Pulmonary Perfusion
2
Cleared 510(K)
K
18
3105
Mimics Medical
2
Cleared 510(K)
K
19
0232
Synapse PACS
2
Cleared 510(K)
K
18
3164
uWS-MR
2
Cleared 510(K)
K
19
0379
MIM on Linux
2
Cleared 510(K)
K
18
3019
SIS Software version 3.3.0
2
Cleared 510(K)
K
18
2537
RADMAX Digital Imaging Software
2
Cleared 510(K)
K
18
2966
PLANET Onco Dose
2
Cleared 510(K)
K
18
1859
Visualase Thermal Therapy System
2
Cleared 510(K)
K
18
3478
ClearON Mobile
2
Cleared 510(K)
K
19
0087
EzDent-i / E2 / Prora View
2
Cleared 510(K)
K
18
2643
IRIS 1.0 System
2
Cleared 510(K)
K
18
2332
PhantomMSK
2
Cleared 510(K)
K
19
0074
Presero 3D Scanning System
2
Cleared 510(K)
K
18
3272
AI Rad Companion (Engine)
2
Cleared 510(K)
K
18
3133
MRCP+ v1.0
2
Cleared 510(K)
K
18
2855
ProKnow DS
2
Cleared 510(K)
K
18
0867
AmCAD-UO
2
Cleared 510(K)
K
18
2564
Quantib ND
2
Cleared 510(K)
K
18
2130
iSchemaView RAPID
2
Cleared 510(K)
K
18
3012
vascuCAP
2
Cleared 510(K)
K
18
2750
4D View
2
Cleared 510(K)
K
17
3041
3DIEMME RealGUIDE
2
Cleared 510(K)
K
18
2624
MIM - MRT Dosimetry
2
Cleared 510(K)
K
18
2601
Vitrea Software Package, VSTP-001A
2
Cleared 510(K)
K
18
2419
Centricity Universal Viewer
2
Cleared 510(K)
K
18
2359
HipCheck
2
Cleared 510(K)
K
18
2926
IntelliSpace Radiology
2
Cleared 510(K)
K
18
2016
Simplicit90Y
2
Cleared 510(K)
K
18
1825
CAAS MR Solutions
2
Cleared 510(K)
K
17
3083
IMPLANTER DENTAL PLANNING SOFTWARE
2
Cleared 510(K)
K
18
2815
XVWeb 3D
2
Cleared 510(K)
K
18
3038
Corin Optimized Positioning System (OPS) Plan
2
Cleared 510(K)
K
18
3013
Vitrea Software Package, VSTP-001A
2
Cleared 510(K)
K
18
2431
Konicaminolta DI-X1
2
Cleared 510(K)
K
17
3744
ProFuse CAD
2
Cleared 510(K)
K
18
1247
Vitrea CT Brain Perfusion
2
Cleared 510(K)
K
17
2999
uWS-MR
2
Cleared 510(K)
K
17
3001
uWS-CT
2
Cleared 510(K)
K
18
1939
icobrain
2
Cleared 510(K)
K
17
1199
AVIEW
2
Cleared 510(K)
K
17
3965
Implant Planning Software
2
Cleared 510(K)
K
18
2464
PeekMed
2
Cleared 510(K)
K
18
1964
JiveX
2
Cleared 510(K)
K
18
2561
UroNav (Version 3.0)
2
Cleared 510(K)
K
18
2034
Arterys MICA
2
Cleared 510(K)
K
18
1460
OnePacs System
2
Cleared 510(K)
K
18
1892
Ziostation2
2
Cleared 510(K)
K
18
2290
IBM iConnect Access
2
Cleared 510(K)
K
18
1773
Synapse 3D Optional Tools
2
Cleared 510(K)
K
18
0916
iNtuition-T1 Mapping and T2/T2* Mapping
2
Cleared 510(K)
K
18
2310
Volpara Imaging Software
2
Cleared 510(K)
K
18
1926
InVivo Web Viewer
2
Cleared 510(K)
K
17
2418
OpenSight
2
Cleared 510(K)
K
18
2230
Multi Modality Viewer
2
Cleared 510(K)
K
18
2208
syngo.via View&GO (Version VA10A)
2
Cleared 510(K)
K
17
0702
mediCAD 4.0
2
Cleared 510(K)
K
18
0006
AmCAD-UT Detection 2.2
2
Cleared 510(K)
K
18
1185
Change Healthcare Enterprise Viewer
2
Cleared 510(K)
K
18
0522
IGTFusion
2
Cleared 510(K)
K
18
1318
ONIS-PACS
2
Cleared 510(K)
K
18
1962
CubeVue
2
Cleared 510(K)
K
17
1435
VirtuOst Vertebral Fracture Assessment
2
Cleared 510(K)
K
17
1977
miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer
2
Cleared 510(K)
K
17
3444
Quantitative Total Extensible Imaging (QTxI)
2
Cleared 510(K)
K
18
0629
DentiqGuide
2
Cleared 510(K)
K
17
3274
Ceevra Reveal 2.0
2
Cleared 510(K)
K
17
3574
DenSeeMammo
2
Cleared 510(K)
K
18
0815
MIM - SPECTRA Quant
2
Cleared 510(K)
K
17
2346
sterEOS Workstation
2
Cleared 510(K)
K
18
1290
Fusion Bx 2.0
2
Cleared 510(K)
K
17
3780
EchoMD Automated Ejection Fraction Software
2
Cleared 510(K)
K
18
1264
QLAB Advanced Quantification Software
2
Cleared 510(K)
K
18
1177
Interventional Workspot
2
Cleared 510(K)
K
18
1080
McKesson Cardiology
2
Cleared 510(K)
K
18
0883
5D Viewer
2
Cleared 510(K)
K
18
0641
Invenia ABUS Viewer
2
Cleared 510(K)
K
17
3390
hipEOS
2
Cleared 510(K)
K
18
0563
syngo.plaza
2
Cleared 510(K)
K
17
2768
ZOOM
2
Cleared 510(K)
K
18
0161
Viz CTP
2
Cleared 510(K)
K
18
0336
syngo.MR Applications
2
Cleared 510(K)
K
17
2477
iSchemaView RAPID
2
Cleared 510(K)
K
18
0549
ZED Link
2
Cleared 510(K)
K
18
0125
PowerLook Density Assessment Software
2
Cleared 510(K)
K
17
3897
syngo.via MI Workflows
2
Cleared 510(K)
K
17
2998
uWS-MI
2
Cleared 510(K)
K
17
1847
Corin Optimized Positioning System (OPS™) Plan
2
Cleared 510(K)
K
17
3597
Scenium VE20 Software
2
Cleared 510(K)
K
17
2239
SIMPLANT 18
2
Cleared 510(K)
K
18
0323
Vitrea Software Package; VSTP-001A
2
Cleared 510(K)
K
17
3241
MED-TAB
2
Cleared 510(K)
K
18
0192
Emprint Ablation Visualization Application
2
Cleared 510(K)
K
17
3619
Mimics inPrint
2
Cleared 510(K)
K
17
2168
WillCeph
2
Cleared 510(K)
K
18
0129
Imbio Segmentation Editing Tool software
2
Cleared 510(K)
K
17
3611
syngo Application Software
2
Cleared 510(K)
K
18
0262
SICAT Endo
2
Cleared 510(K)
K
18
0394
BrightMatter Plan 1.6.0
2
Cleared 510(K)
K
17
3939
Quantib Brain
2
Cleared 510(K)
K
18
0326
icobrain
2
Cleared 510(K)
K
17
3605
iQMR
2
Cleared 510(K)
K
17
3312
ProBx Software
2
Cleared 510(K)
K
17
3145
CereMetrix Silver
2
Cleared 510(K)
K
17
3863
Ez3D-i /E3
2
Cleared 510(K)
K
17
0540
DM-Density
2
Cleared 510(K)
K
17
3636
Velocity
2
Cleared 510(K)
K
17
0793
SuRgical Planner (SRP)
2
Cleared 510(K)
K
18
0091
UNiD Spine Analyzer
2
Cleared 510(K)
K
16
2727
SENYINT Remote Consultation System
2
Cleared 510(K)
K
17
2832
Insight BD
2
Cleared 510(K)
K
17
2490
eUnity
2
Cleared 510(K)
K
17
3512
MFI-Cardiac
2
Cleared 510(K)
K
17
3088
Vitrea Software Toshiba Package VSTP-001A
2
Cleared 510(K)
K
17
3542
Arterys Oncology DL
2
Cleared 510(K)
K
17
3622
CS Imaging
2
Cleared 510(K)
K
17
3054
Navigo Workstation Version 2.0
2
Cleared 510(K)
K
17
3588
Illumeo System
2
Cleared 510(K)
K
17
2224
DTX Studio diagnose
2
Cleared 510(K)
K
17
1328
cNeuro cMRI
2
Cleared 510(K)
K
17
3456
ViewPoint 6
2
Cleared 510(K)
K
17
3420
Radiomics App v1.0
2
Cleared 510(K)
K
17
3467
Advanced Diffusion Analysis (ADA) application
2
Cleared 510(K)
K
17
3475
Merge PACS
2
Cleared 510(K)
K
17
2218
MIM – Y90 Dosimetry
2
Cleared 510(K)
K
17
3378
syngo®.via protoNeo (Version VA20)
2
Cleared 510(K)
K
17
3329
jFit Surgical Planner
2
Cleared 510(K)
K
17
1385
Planmeca Romexis
2
Cleared 510(K)
K
17
3247
Surgical Planning Software version 1.1
2
Cleared 510(K)
K
17
2803
Infinitt PACS 7.0
2
Cleared 510(K)
K
17
3094
OrthoVision
2
Cleared 510(K)
K
17
1709
BR-FHUS Viewer 1.0
2
Cleared 510(K)
K
16
3623
Quantra
2
Cleared 510(K)
K
17
3101
Curve Image 2.0 PACS
2
Cleared 510(K)
K
17
1068
OrthoView 7.2
2
Cleared 510(K)
K
17
2855
Vitrea Advanced Visualization, Version 7.6
2
Cleared 510(K)
K
17
1463
ASPIRE Bellus II
2
Cleared 510(K)
K
17
0816
Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM
2
Cleared 510(K)
K
17
2513
3D Echo
2
Cleared 510(K)
K
17
0981
NeuroQuant
2
Cleared 510(K)
K
17
2327
VMA™ System version 3.0
2
Cleared 510(K)
K
17
2364
EzDent-i / E2 / Prora View
2
Cleared 510(K)
K
17
1617
OKI Surgical Planning Software
2
Cleared 510(K)
K
17
1356
Clarity Reveal
2
Cleared 510(K)
K
17
1754
NovaPACS
2
Cleared 510(K)
K
16
3048
Smart Stitching Software System, Image Processing, Radiological
2
Cleared 510(K)
K
17
0841
BiopSee, Mobile US
2
Cleared 510(K)
K
16
3232
Vitrea View
2
Cleared 510(K)
K
17
1544
Arterys Viewer
2
Cleared 510(K)
K
17
0729
Examion X-AQS
2
Cleared 510(K)
K
17
1115
3D Endo Software
2
Cleared 510(K)
K
17
0434
Enterprise Imaging XERO Viewer 8.1
2
Cleared 510(K)
K
16
3668
SUITESTENSA
2
Cleared 510(K)
K
17
0847
EchoPAC Software Only, EchoPAC Plug-in
2
Cleared 510(K)
K
17
0747
syngo Application Software
2
Cleared 510(K)
K
17
1222
Vitrea Software Toshiba Package; VSTP-001A
2
Cleared 510(K)
K
17
0250
SmartTarget
2
Cleared 510(K)
K
17
1053
syngo Dynamics Version VA30
2
Cleared 510(K)
K
17
1314
QLAB Advanced Quantification Software
2
Cleared 510(K)
K
16
2574
AmCAD-US
2
Cleared 510(K)
K
17
0172
UNiD Spine Analyzer
2
Cleared 510(K)
K
16
3071
vascuCAP
2
Cleared 510(K)
K
17
0195
QuantX
2
Cleared 510(K)
K
16
1601
Dynamika
2
Cleared 510(K)
K
17
0419
SurgiCase Viewer
2
Cleared 510(K)
K
16
3622
Lung Vision
2
Cleared 510(K)
K
16
3250
Longitudinal Brain Imaging (LoBI) application
2
Cleared 510(K)
K
17
0180
Will3D
2
Cleared 510(K)
K
17
1130
Nucleus Image Management System
2
Cleared 510(K)
K
16
3119
NaviSuite SSI Edition
2
Cleared 510(K)
K
16
2647
NuVasive NuvaLine Mobile App
2
Cleared 510(K)
K
17
0952
syngo.CT View&GO
2
Cleared 510(K)
K
17
0069
AmCAD-UV
2
Cleared 510(K)
K
16
2799
Cliniview
2
Cleared 510(K)
K
17
0580
Carestream Vue PACS
2
Cleared 510(K)
K
16
2287
Synapse 3D Perfusion Analysis
2
Cleared 510(K)
K
16
3076
Segment CMR
2
Cleared 510(K)
K
16
1341
LIFESYS PACS
2
Cleared 510(K)
K
16
2559
Move Forward 3D Motion Simulation Service
2
Cleared 510(K)
K
16
3290
INFINITT ULite
2
Cleared 510(K)
K
16
3405
360KS Implant Positioning System
2
Cleared 510(K)
K
16
2868
Exam Vue PACS
2
Cleared 510(K)
K
17
0451
FDX Console (DR-ID300CL) Software
2
Cleared 510(K)
K
17
0167
True 3D Viewer Software
2
Cleared 510(K)
K
16
2484
Lung Nodule Assessment and Comparison Option (LNA)
2
Cleared 510(K)
K
16
3285
syngo Application Software
2
Cleared 510(K)
K
16
2830
SIS Software
2
Cleared 510(K)
K
16
3294
syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology
2
Cleared 510(K)
K
16
0934
UC-CARE NaviGo Workstation
2
Cleared 510(K)
K
16
3122
NobelClinician, DTX Studio implant
2
Cleared 510(K)
K
16
3324
nordicBrainEx
2
Cleared 510(K)
K
16
2285
EBM iDO Viewer 1.2.1
2
Cleared 510(K)
K
16
3574
Multi Modality Viewer
2
Cleared 510(K)
K
16
3533
EzDent-i; E2; ProraView
2
Cleared 510(K)
K
16
1841
D2P
2
Cleared 510(K)
K
16
3013
Quantib Brain 1.2
2
Cleared 510(K)
K
16
3253
Arterys Cardio DL
2
Cleared 510(K)
K
16
1270
CephSimulation
2
Cleared 510(K)
K
16
3421
syngo.via MI Workflows
2
Cleared 510(K)
K
16
1959
ClearView cCAD
2
Cleared 510(K)
K
16
3539
Ez3D-i / E3
2
Cleared 510(K)
K
16
2955
Multi-Modality Tumor Tracking (MMTT) application
2
Cleared 510(K)
K
16
0852
Zia
2
Cleared 510(K)
K
16
2376
CAAS MR 4D Flow
2
Cleared 510(K)
K
16
1322
CT CoPilot
2
Cleared 510(K)
K
15
2009
DENSEEMAMMO v1.0
2
Cleared 510(K)
K
16
3158
MEDSYNAPSE Zero Footprint Viewer
2
Cleared 510(K)
K
16
2743
ViewPoint 6
2
Cleared 510(K)
K
16
2541
syngo Application Software
2
Cleared 510(K)
K
16
1515
eUnity
2
Cleared 510(K)
K
16
1634
IPS CaseDesigner
2
Cleared 510(K)
K
16
2513
Arterys Software v2.0
2
Cleared 510(K)
K
16
2145
vRad PACS with Mammography
2
Cleared 510(K)
K
16
2474
Artemis
2
Cleared 510(K)
K
16
2025
IntelliSpace Portal Platform
2
Cleared 510(K)
K
16
2011
MedDream
2
Cleared 510(K)
K
16
0371
NovaPACS
2
Cleared 510(K)
K
16
1109
iSR'obot MRI-US Fusion
2
Cleared 510(K)
K
16
0666
Dentiq3D
2
Cleared 510(K)
K
16
1828
kneeEOS
2
Cleared 510(K)
K
16
2339
Scenium
2
Cleared 510(K)
K
16
2112
CAAS MRV
2
Cleared 510(K)
K
16
1625
PixelShine
2
Cleared 510(K)
K
16
2008
JiveX
2
Cleared 510(K)
K
16
2141
Restore PACS
2
Cleared 510(K)
K
15
3705
PROcedure Rehearsal Studio
2
Cleared 510(K)
K
16
1130
ResolutionMD
2
Cleared 510(K)
K
16
1518
PACS CORE/ENCORE
2
Cleared 510(K)
K
15
2949
WebPAX
2
Cleared 510(K)
K
16
1955
5D Viewer
2
Cleared 510(K)
K
16
1148
icobrain
2
Cleared 510(K)
K
16
1113
QXLink
2
Cleared 510(K)
K
16
0284
JointPoint
2
Cleared 510(K)
K
16
0937
Senolris
2
Cleared 510(K)
K
16
1382
LVivo Software Application
2
Cleared 510(K)
K
16
1118
SIMPLANT Online Case Review and SIMPLANT Editor
2
Cleared 510(K)
K
16
1419
Multi Modality Viewer
2
Cleared 510(K)
K
16
1685
syngo®.via protoNeo (Version VA10A)
2
Cleared 510(K)
K
16
1479
hipEOS
2
Cleared 510(K)
K
16
0584
Surgical Navigation Advanced Platform (SNAP)
2
Cleared 510(K)
K
16
1559
Kuvia3D
2
Cleared 510(K)
K
16
1061
IMPAX Volume Viewing 4.0
2
Cleared 510(K)
K
16
1444
DBSWIN and VistaEasy Imaging Software
2
Cleared 510(K)
K
16
0334
Advanced Medical Imaging Software Suite (KSWVWR)
2
Cleared 510(K)
K
15
3351
Quantib Brain 1
2
Cleared 510(K)
K
16
1188
HEPATIQ 1.1
2
Cleared 510(K)
K
16
1246
Ez3D-i / E3
2
Cleared 510(K)
K
15
3736
3mensio Workstation
2
Cleared 510(K)
K
16
1117
EzDent-i / E2 / Prora View
2
Cleared 510(K)
K
15
1913
MIM-Thin Client (mobile)
2
Cleared 510(K)
K
16
0914
sterEOS Workstation
2
Cleared 510(K)
K
15
3653
DICOM Viewer
2
Cleared 510(K)
K
16
0376
EndoSize
2
Cleared 510(K)
K
16
0579
Xmaru View V1 and Xmaru PACS, Medical Image Processing Software
2
Cleared 510(K)
K
16
0407
spineEOS
2
Cleared 510(K)
K
15
3284
Synaptive ImageDrive Pro
2
Cleared 510(K)
K
15
2716
EV Insite System
2
Cleared 510(K)
K
16
0150
Vitrea CT Colon Analysis
2
Cleared 510(K)
K
15
3355
Xeleris 4.0 Processing and Review Workstation
2
Cleared 510(K)
K
15
3612
ArthrexVIP Web Portal
2
Cleared 510(K)
K
16
0426
syngo.via MI Workflows
2
Cleared 510(K)
K
15
3346
syngo Application Software VD11
2
Cleared 510(K)
K
15
2602
Olea Sphere V3.0
2
Cleared 510(K)
K
16
0317
syngo.via MI Workflows
2
Cleared 510(K)
K
15
3091
IMPLANT 3D
2
Cleared 510(K)
K
15
1737
MedicVOD System
2
Cleared 510(K)
K
15
2034
FS-PACS
2
Cleared 510(K)
K
16
0315
I4 (Integrated Intelligent Imaging Informatics) system
2
Cleared 510(K)
K
14
3290
DBSWIN and VistaEasy Imaging Software
2
Cleared 510(K)
K
15
3593
CliniscanSM MRI
2
Cleared 510(K)
K
16
0001
TraumaCad Mobile Release 2.0
2
Cleared 510(K)
K
15
3103
CARESTREAM Vue PACS
2
Cleared 510(K)
K
16
0108
Synapse PACS
2
Cleared 510(K)
K
15
3166
Fusion Bx
2
Cleared 510(K)
K
15
2977
DG PACS
2
Cleared 510(K)
K
15
2352
Stereo 3D option for Vision Applications
2
Cleared 510(K)
K
15
3289
HEALTHMYNE
2
Cleared 510(K)
K
15
1075
BR-ABVS Viewer 1.0
2
Cleared 510(K)
K
15
1152
ImplantMax Software
2
Cleared 510(K)
K
15
3427
Volpara Imaging Software
2
Cleared 510(K)
K
15
2746
Ez3D Plus
2
Cleared 510(K)
K
15
2172
Econsole1
2
Cleared 510(K)
K
15
2078
Implant Studio 2015
2
Cleared 510(K)
K
15
2822
VidiStar HeartView
2
Cleared 510(K)
K
15
3022
Philips IntelliSpace Cardiovascular
2
Cleared 510(K)
K
15
3073
UroNav (Version 2.0)
2
Cleared 510(K)
K
15
2661
HICAT Air
2
Cleared 510(K)
K
15
1212
Ziostation2
2
Cleared 510(K)
K
15
2028
Volpara Imaging Software
2
Cleared 510(K)
K
15
1988
Visible Patient Suite
2
Cleared 510(K)
K
15
1941
DEXIS Webview
2
Cleared 510(K)
K
15
1501
OrthoVis Web Portal
2
Cleared 510(K)
K
15
1774
CARESTREAM Vue Motion
2
Cleared 510(K)
K
14
3586
FACT Medical Imaging Sysytem
2
Cleared 510(K)
K
15
1957
BOX DICOM Viewer
2
Cleared 510(K)
K
15
2186
HealthMyne PACS
2
Cleared 510(K)
K
15
1837
CS 3D Imaging
2
Cleared 510(K)
K
15
1371
Corporate Dental Imaging (CDI) Application
2
Cleared 510(K)
K
15
1859
Synapse Cardiovascular
2
Cleared 510(K)
K
15
1850
McKesson Cardiology
2
Cleared 510(K)
K
15
1353
syngo.MR Neurology, syngo.MR Oncology
2
Cleared 510(K)
K
15
1687
QuantorView
2
Cleared 510(K)
K
15
1568
Arthrex OrthoVis Preoperative Plan
2
Cleared 510(K)
K
15
1808
3D/5D Viewer
2
Cleared 510(K)
K
14
3368
GenIQ
2
Cleared 510(K)
K
15
1854
3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display
2
Cleared 510(K)
K
14
3176
UltraLinq
2
Cleared 510(K)
K
15
1091
Vitrea Software Toshiba Package, VSTP-001A
2
Cleared 510(K)
K
15
0313
Ablation Confirmation
2
Cleared 510(K)
K
15
1438
Dentrix Ascend Imaging
2
Cleared 510(K)
K
14
2750
JiveX
2
Cleared 510(K)
K
15
1192
syngo.via MI Workflows
2
Cleared 510(K)
K
15
0415
NilRead
2
Cleared 510(K)
K
15
0761
Ez3D-i/E3
2
Cleared 510(K)
K
15
0976
Collage
2
Cleared 510(K)
K
15
1115
MR Core Software
2
Cleared 510(K)
K
14
3397
ICIS View
2
Cleared 510(K)
K
15
0707
IntelePACS
2
Cleared 510(K)
K
15
0420
Centricity Universal Viewer
2
Cleared 510(K)
K
15
0069
Fine Structure Analysis(fineSA)
2
Cleared 510(K)
K
14
2648
SPINEDESIGN Spine Surgery Planning (Software Application)
2
Cleared 510(K)
K
14
2196
Visage Ease Pro
2
Cleared 510(K)
K
15
0843
syngo®.via (version VB10A)
2
Cleared 510(K)
K
14
2779
SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED
2
Cleared 510(K)
K
14
2647
mint Lesion
2
Cleared 510(K)
K
15
0738
VitreaView
2
Cleared 510(K)
K
15
0747
EzDent-i /E2/Prora View
2
Cleared 510(K)
K
15
0192
Scenium
2
Cleared 510(K)
K
14
3361
Mammo Workstation
2
Cleared 510(K)
K
15
0193
Customer Remote Console (CRC)
2
Cleared 510(K)
K
14
2337
Blackford Analysis Registration Product Family
2
Cleared 510(K)
K
14
3318
DR Systems Zero Download 3D Viewer (Z3D)
2
Cleared 510(K)
K
14
1536
VIEWING CLIENT MOBILE
2
Cleared 510(K)
K
15
0258
Vitrea, Version 7.0 Medical Image Processing Software
2
Cleared 510(K)
K
14
2923
TraumaCad Mobile Release 1.0
2
Cleared 510(K)
K
15
0085
GE EchoPAC
2
Cleared 510(K)
K
14
3319
Syngo X-workplace SW VD10
2
Cleared 510(K)
K
15
0122
TOMTEC-ARENA TTA2
2
Cleared 510(K)
K
14
3044
CAAS A-Valve
2
Cleared 510(K)
K
14
0828
NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE
2
Cleared 510(K)
K
14
2107
ECHO TRUE 3D VIEWER
2
Cleared 510(K)
K
14
1561
VM PACS WITH VM MEDICAL WORKSTATION
2
Cleared 510(K)
K
14
2850
McKesson Radiology Mammography Plus
2
Cleared 510(K)
K
14
2316
IMPAX Agility
2
Cleared 510(K)
K
14
0587
MR-CT VVA
2
Cleared 510(K)
K
14
2514
UniWeb 8.0
2
Cleared 510(K)
K
14
2891
HEPATIQ
2
Cleared 510(K)
K
14
2944
ArthroPlan Digital Templating Software
2
Cleared 510(K)
K
14
2919
EXA
2
Cleared 510(K)
K
14
0860
ImmersiveTouch3 and MicrovisTouch
2
Cleared 510(K)
K
14
0797
IPACS MEDICAL IMAGE MANAGEMENT SYSTEM
2
Cleared 510(K)
K
14
3254
eSie Apps Suite
2
Cleared 510(K)
K
14
2671
ONEFIT HIP PLANNER
2
Cleared 510(K)
K
14
3079
Endovascular Stent Planning Software
2
Cleared 510(K)
K
14
2521
Synapse 3D Liver and Kidney Analysis
2
Cleared 510(K)
K
14
1881
RAPIDRESULTS
2
Cleared 510(K)
K
14
1745
IQQA-BODYIMAGING SOFTWARE
2
Cleared 510(K)
K
14
1570
IMPLANT STUDIO
2
Cleared 510(K)
K
13
2853
NOVAPACS
2
Cleared 510(K)
K
14
2037
QUANTRA
2
Cleared 510(K)
K
14
1669
SURGIMAP
2
Cleared 510(K)
K
14
1607
DENTAL IMAGING SOFTWARE
2
Cleared 510(K)
K
14
0399
EBM IDO VIEWER
2
Cleared 510(K)
K
14
2048
EMPRINT PROCEDURE PLANNING APPLICATION
2
Cleared 510(K)
K
14
1137
STEREOS WORKSTATION
2
Cleared 510(K)
K
14
1514
SYNAPSE 3D TENSOR ANALYSIS
2
Cleared 510(K)
K
14
1364
CLIMB MAMMOGRAPHY VIEWER SOFTWARE
2
Cleared 510(K)
K
14
1451
VixWin Platinum
2
Cleared 510(K)
K
14
1480
CVI42
2
Cleared 510(K)
K
13
1348
ORTOMED
2
Cleared 510(K)
K
14
1302
VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)
2
Cleared 510(K)
K
14
1061
REMOTEYE VIEWER
2
Cleared 510(K)
K
14
1475
ENDOSIZE
2
Cleared 510(K)
K
14
0897
SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL
2
Cleared 510(K)
K
14
1554
ESIE APPS SUITE
2
Cleared 510(K)
K
14
0869
DCAS I
2
Cleared 510(K)
K
14
1556
AVREO INTERWORKS SYSTEM
2
Cleared 510(K)
K
14
0909
MCKESSON RADIOLOGY
2
Cleared 510(K)
K
14
0819
SURGICAL NAVIGATION ADVANCED PLATFORM
2
Cleared 510(K)
K
14
1329
RADSPA
2
Cleared 510(K)
K
14
1199
QUENTRY DOSE REVIEW
2
Cleared 510(K)
K
14
0713
PLANMECA ROMEXIS
2
Cleared 510(K)
K
14
0960
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
2
Cleared 510(K)
K
13
3098
SENYINT PACS
2
Cleared 510(K)
K
14
0434
MEDICAD CLASSIC
2
Cleared 510(K)
K
14
0337
BRIGHTMATTER PLANNING SOFTWARE
2
Cleared 510(K)
K
14
0139
CLEARVIEWHD
2
Cleared 510(K)
K
13
2684
MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO)
2
Cleared 510(K)
K
14
0395
VITREA IMAGE DENOISING SOFTWARE
2
Cleared 510(K)
K
14
0445
DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC
2
Cleared 510(K)
K
14
0808
Q-STATION
2
Cleared 510(K)
K
13
3521
AZE PHOENIX SOFTWARE
2
Cleared 510(K)
K
13
3910
NORDICBRAINEX
2
Cleared 510(K)
K
14
0271
TABLET VIEWER SOFTWARE FOR IMAGE SUITE
2
Cleared 510(K)
K
13
3984
CORONIS 5MP
2
Cleared 510(K)
K
13
3508
RESOLUTIONMD MOBILE
2
Cleared 510(K)
K
13
3663
NIO COLOR 2MP
2
Cleared 510(K)
K
13
3401
SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL
2
Cleared 510(K)
K
14
0093
TABLE
2
Cleared 510(K)
K
13
3135
IMPAX VOLUME VIEWING 3.0
2
Cleared 510(K)
K
13
3966
MODEL-BASED RSA SOFTWARE
2
Cleared 510(K)
K
13
3022
ZEDVIEW
2
Cleared 510(K)
K
13
3937
HEARTSCAN SOFTWARE
2
Cleared 510(K)
K
13
3654
SCENIUM
2
Cleared 510(K)
K
13
3609
THE DOME S6C
2
Cleared 510(K)
K
13
2763
ADVANCED VIEWER
2
Cleared 510(K)
K
14
0033
TARGET3D FUSION
2
Cleared 510(K)
K
13
3385
LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE
2
Cleared 510(K)
K
13
3644
SYNGO.VIA MI WORKFLOWS
2
Cleared 510(K)
K
13
3320
SICAT FUNCTION
2
Cleared 510(K)
K
14
0214
30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6)
2
Cleared 510(K)
K
14
0103
3MP GRAYSCAKE LCD DISPLAY
2
Cleared 510(K)
K
14
0108
3MP COLOR LCD DISPLAY
2
Cleared 510(K)
K
13
3708
MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR
2
Cleared 510(K)
K
13
2824
CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION
2
Cleared 510(K)
K
13
4002
6MP COLOR LCD MONITOR, RADIFORCE RX650
2
Cleared 510(K)
K
13
3730
CO PILOT/REGIUS UNITEA
2
Cleared 510(K)
K
13
2770
DOME S10
2
Cleared 510(K)
K
13
3030
DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)
2
Cleared 510(K)
K
13
2499
ICRCO CLARITY VIEWER
2
Cleared 510(K)
K
13
3875
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA
2
Cleared 510(K)
K
13
3686
21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)
2
Cleared 510(K)
K
13
0998
SYNGO.VIA WEB VIEWER
2
Cleared 510(K)
K
13
2095
OLEA SPHERE
2
Cleared 510(K)
K
13
1447
INTUITION - TDA, TVA, PARAMETRIC MAPPING
2
Cleared 510(K)
K
13
3367
ORTHOVIS PREOPERATIVE PLAN
2
Cleared 510(K)
K
13
2342
XVWEB
2
Cleared 510(K)
K
13
3511
21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025)
2
Cleared 510(K)
K
13
2963
FUSIONSYNC, CHIMAERA FUSIONSYNC
2
Cleared 510(K)
K
13
2773
SIDEXIS 4
2
Cleared 510(K)
K
13
2532
SYNGO.PLAZA VB10A
2
Cleared 510(K)
K
13
3185
21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358)
2
Cleared 510(K)
K
13
3181
21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258)
2
Cleared 510(K)
K
13
2742
M-VU BREAST DENSITY
2
Cleared 510(K)
K
13
1390
JUSHA-M52C MEDICAL DISPLAY
2
Cleared 510(K)
K
13
3357
CHARRUAPACS SYSTEM
2
Cleared 510(K)
K
13
2544
TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
2
Cleared 510(K)
K
13
2799
CLARISO PACS
2
Cleared 510(K)
K
13
2586
PAXERAPACS
2
Cleared 510(K)
K
13
2316
MULTIVIEW
2
Cleared 510(K)
K
13
2188
MAMMOGRAPHY VIEWER SMV658
2
Cleared 510(K)
K
13
2636
DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM
2
Cleared 510(K)
K
12
1447
ISCHEMA VIEW RAPID
2
Cleared 510(K)
K
12
2536
AMCAD-UT DETECTION MODEL 2.0
2
Cleared 510(K)
K
13
1873
NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)
2
Cleared 510(K)
K
13
1685
GE ECHOPAC
2
Cleared 510(K)
K
13
1977
CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
2
Cleared 510(K)
K
13
2302
QXLINK
2
Cleared 510(K)
K
13
1389
JUSHA-C31 MEDICAL DISPLAY
2
Cleared 510(K)
K
12
3944
KOSTEC MEDICAL GRADE LDC MONITORS
2
Cleared 510(K)
K
13
2610
5MP GRAYSCALE LCD DISPLAY
2
Cleared 510(K)
K
13
2587
MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR
2
Cleared 510(K)
K
13
1594
EZDENTI-I; E2; PRORA VIEW
2
Cleared 510(K)
K
13
1616
EZ3D-I, E3
2
Cleared 510(K)
K
13
0374
OMNI-VUE 2 SYSTEM
2
Cleared 510(K)
K
13
0242
MAVEN PRO
2
Cleared 510(K)
K
13
1391
JUSHA-M32 MEDICAL DISPLAY
2
Cleared 510(K)
K
13
1158
CORVIEW
2
Cleared 510(K)
K
13
0749
SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR
2
Cleared 510(K)
K
13
1570
ORTHOVISION
2
Cleared 510(K)
K
13
0779
LVIVO EF SYSTEM
2
Cleared 510(K)
K
13
2165
QLAB QUANTIFICATION SOFTWARE
2
Cleared 510(K)
K
13
0743
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL
2
Cleared 510(K)
K
13
1448
3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION
2
Cleared 510(K)
K
13
1498
IQQA-LIVER MULTIMODALITY SOFTWARE
2
Cleared 510(K)
K
13
2062
ESIE APPS SUITE
2
Cleared 510(K)
K
13
1822
ULTRAEXTEND USWS-900A V2.1 AND V3.1
2
Cleared 510(K)
K
13
1137
21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)
2
Cleared 510(K)
K
13
1424
MIPLATFORM MEDICAL IMAGING SUITE
2
Cleared 510(K)
K
13
1090
2MP COLOR LCD MONITOR, RADIFORCE MX215
2
Cleared 510(K)
K
13
0724
CODIAGNOSTIX IMPLANT PLANNING SOFTWARE
2
Cleared 510(K)
K
13
0542
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
2
Cleared 510(K)
K
13
1392
ETIAM PACS COMPONENTS
2
Cleared 510(K)
K
13
1295
NIO COLOR 3MP LED
2
Cleared 510(K)
K
13
0278
MR PERMEABILITY
2
Cleared 510(K)
K
13
1246
CORONIS 3MP
2
Cleared 510(K)
K
13
1299
ANYTHINK PACS WORKSTATION
2
Cleared 510(K)
K
12
3306
NORDIC TUMOREX
2
Cleared 510(K)
K
12
4051
THE VAULT SYSTEM
2
Cleared 510(K)
K
13
1118
4D VIEW
2
Cleared 510(K)
K
12
3082
MOBILECT VIEWER
2
Cleared 510(K)
K
13
0159
QLAB QUANTIFICATION SOFTWARE HEART MODEL
2
Cleared 510(K)
K
13
0624
CONI
2
Cleared 510(K)
K
13
0772
MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR
2
Cleared 510(K)
K
13
0770
MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR
2
Cleared 510(K)
K
13
0929
ZMED VP4000
2
Cleared 510(K)
K
13
0884
XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION
2
Cleared 510(K)
K
13
0383
SYNAPSE 3D CARDIAC TOOLS
2
Cleared 510(K)
K
13
0069
INNOVA EPVISION 2.0, INNOVA EPVISION 2.0
2
Cleared 510(K)
K
12
1916
INTUITION
2
Cleared 510(K)
K
13
0336
5MP MONOCHROME LCD MONITOR, RADIFORCE GX540
2
Cleared 510(K)
K
12
3976
NOBELCLINICIAN
2
Cleared 510(K)
K
13
0393
MIRADA RTX
2
Cleared 510(K)
K
13
0228
SUITEHEART
2
Cleared 510(K)
K
12
3186
RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31
2
Cleared 510(K)
K
13
0395
STEREOS WORKSTATION
2
Cleared 510(K)
K
12
3426
MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS
2
Cleared 510(K)
K
12
2578
VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
2
Cleared 510(K)
K
12
3650
ARIX RAD ACQUISITION CONSOLE
2
Cleared 510(K)
K
12
3575
MAMMOWORKSTATION
2
Cleared 510(K)
K
12
0851
COMMUNIFY PACS VIEWER
2
Cleared 510(K)
K
13
0103
CORONIS FUSION 6MP
2
Cleared 510(K)
K
13
0070
4MP COLOR LCD MONITOR, RADIFORCE RX440
2
Cleared 510(K)
K
12
3023
SURGERY REHEARSAL PLATFORM
2
Cleared 510(K)
K
12
3970
CAAS INTRAVASCULAR
2
Cleared 510(K)
K
12
3519
INVIVO DENTAL
2
Cleared 510(K)
K
12
3420
SYNGO, BREAST CARE
2
Cleared 510(K)
K
12
4048
IMAGEQUBE
2
Cleared 510(K)
K
12
3901
TRACTUS TISSUEMAPPER REVIEWER APPLICATION
2
Cleared 510(K)
K
12
3894
GE ECHOPAC
2
Cleared 510(K)
K
12
3269
PROCEDURE REHEARSAL STUDIO
2
Cleared 510(K)
K
12
3577
SYNGO.VIA MI WORKFLOWS
2
Cleared 510(K)
K
12
3566
SYNAPSE 3D COLON ANALYSIS
2
Cleared 510(K)
K
12
3920
SYNGO.VIA
2
Cleared 510(K)
K
12
1762
CARDIAC VX
2
Cleared 510(K)
K
12
3922
SYNGO DYNAMICS
2
Cleared 510(K)
K
12
3302
IB CLINIC
2
Cleared 510(K)
K
12
1296
INTERVENTIONAL WORKSPOT
2
Cleared 510(K)
K
12
3526
CLEARREAD +CONFIRM
2
Cleared 510(K)
K
12
3530
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
2
Cleared 510(K)
K
12
3528
SCENIUM
2
Cleared 510(K)
K
12
0995
ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT
2
Cleared 510(K)
K
12
2429
VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL
2
Cleared 510(K)
K
12
3375
SYNGO.VIA
2
Cleared 510(K)
K
12
3174
CENTRICITY PACS-IW WITH UNIVERSAL VIEWER
2
Cleared 510(K)
K
11
3344
STEREOS WORKSTATION
2
Cleared 510(K)
K
12
1213
VITREAADVANCED
2
Cleared 510(K)
K
12
1200
FLIGHTPLAN FOR LIVER
2
Cleared 510(K)
K
12
1781
ECHONAVIGATOR RELEASE 1
2
Cleared 510(K)
K
12
2289
IMAGE-COM 5.0
2
Cleared 510(K)
K
12
2523
CARESTREAM VUE PACS
2
Cleared 510(K)
K
12
1076
ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE
2
Cleared 510(K)
K
12
2843
MD211G3 21.3 DIAGNOSTIC IMAGING LCD MONITOR
2
Cleared 510(K)
K
12
2022
ATHEROEDGE
2
Cleared 510(K)
K
11
1142
ECHOSOFT(TM)
2
Cleared 510(K)
K
12
0288
ORTHOCAD SOFTWARE OPTION
2
Cleared 510(K)
K
12
2427
CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE
2
Cleared 510(K)
K
12
2260
AYCAN MOBILE
2
Cleared 510(K)
K
12
2164
MR VESSELLQ XPRESS
2
Cleared 510(K)
K
12
2136
VITREAVIEW
2
Cleared 510(K)
K
12
2329
BIOJET
2
Cleared 510(K)
K
12
2205
EXINI
2
Cleared 510(K)
K
12
0451
8MP COLOR LCD MONITOR, REDIFORCE RX840
2
Cleared 510(K)
K
12
0734
MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE
2
Cleared 510(K)
K
12
1292
DYNAPBV BODY SOFTWARE
2
Cleared 510(K)
K
12
1075
NERVEVISION SOFTWARE SYSTEMS
2
Cleared 510(K)
K
12
1788
NIO 5MP
2
Cleared 510(K)
K
12
1517
VERSAVUE ENTERPRISE SUITE
2
Cleared 510(K)
K
11
3562
3MP COLOR LCD MONITOR, RADIFORCE RX340
2
Cleared 510(K)
K
11
3620
MYRIAN 1.11
2
Cleared 510(K)
K
12
1449
DIRECTPATH
2
Cleared 510(K)
K
12
0305
THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV
2
Cleared 510(K)
K
12
0733
SIMPLANT GO
2
Cleared 510(K)
K
12
0636
SYNAPSE 3D CARDIAC TOOLS
2
Cleared 510(K)
K
12
0514
CARDIOPACS
2
Cleared 510(K)
K
12
1459
SYNGO.MR NEUROLOGY
2
Cleared 510(K)
K
12
0472
QUANTRA
2
Cleared 510(K)
K
11
3456
READY VIEW
2
Cleared 510(K)
K
12
0648
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
2
Cleared 510(K)
K
12
1074
SCENIUM 2.0
2
Cleared 510(K)
K
12
1387
CENTRICITY PACS-IW
2
Cleared 510(K)
K
12
0679
SYNAPSE 3D NODULE ANALYSIS
2
Cleared 510(K)
K
12
1466
GUIDEMIA
2
Cleared 510(K)
K
12
1023
SPECTRUM V.0
2
Cleared 510(K)
K
11
3739
SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM
2
Cleared 510(K)
K
12
1223
QLAB WITH FHN AND VPQ PLUG-IN
2
Cleared 510(K)
K
12
0637
SYNAPSE 3D BRAIN PERFUSION
2
Cleared 510(K)
K
11
3599
SURGICASE CONNECT
2
Cleared 510(K)
K
12
0207
VISIA
2
Cleared 510(K)
K
11
3240
3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W
2
Cleared 510(K)
K
12
0718
INSTAPACS/INSTARISPACS
2
Cleared 510(K)
K
12
0407
2MP MONOCHROME LCD MONITOR, RADIFORCE GX240
2
Cleared 510(K)
K
12
0196
OLEA SPHERE
2
Cleared 510(K)
K
12
0076
RESOLUTIONMD WEB
2
Cleared 510(K)
K
12
0367
3MENSIO WORKSTATION
2
Cleared 510(K)
K
12
0315
SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION
2
Cleared 510(K)
K
12
0161
ALPHAPOINT IMAGING SOFTWARE
2
Cleared 510(K)
K
12
0135
2D CARDIAC PERFORMANCE ANALYSIS MR 1.0
2
Cleared 510(K)
K
12
0709
THE DOME GX4MP COLOR NONITOR
2
Cleared 510(K)
K
12
0361
SYNAPSE 3D BASE TOOLS
2
Cleared 510(K)
K
12
0187
MULTI-MODALITY IMAGE FUSION
2
Cleared 510(K)
K
12
0221
GE ECHOPAC
2
Cleared 510(K)
K
12
0484
VISIA ONCOLOGY
2
Cleared 510(K)
K
12
0115
ORTHOSIZE
2
Cleared 510(K)
K
12
0525
QLAB QUANTIFICATION SOFTWARE
2
Cleared 510(K)
K
11
3082
SONOVISION
2
Cleared 510(K)
K
11
3784
3MP MONOCHROME LCD MONITOR, RADIFORCE GX340
2
Cleared 510(K)
K
11
3844
RADIFORCE RX240
2
Cleared 510(K)
K
11
2807
X-RAY VVA
2
Cleared 510(K)
K
11
2679
SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM
2
Cleared 510(K)
K
11
3701
VISIA NEURO
2
Cleared 510(K)
K
11
3442
3DI
2
Cleared 510(K)
K
11
3419
CS IMAGING
2
Cleared 510(K)
K
11
1758
CADENS (TM) COLON
2
Cleared 510(K)
K
11
3076
CAAS A-VALVE
2
Cleared 510(K)
K
11
2720
MCKESSON HORIZON CARDIOLOGY
2
Cleared 510(K)
K
11
1385
DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE
2
Cleared 510(K)
K
11
2251
SWISSMEDA DENTAL PLANNING SYSTEM
2
Cleared 510(K)
K
11
2008
TOUCHPACS SUITE
2
Cleared 510(K)
K
11
1861
SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE
2
Cleared 510(K)
K
11
1776
DELTAVIEW MODEL 2.1
2
Cleared 510(K)
K
11
2387
PROCEDURE REHEARSAL STUDIO(TM)
2
Cleared 510(K)
K
11
3443
21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)
2
Cleared 510(K)
K
11
3244
SYNAPSE MPR FUSION
2
Cleared 510(K)
K
11
2109
THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE
2
Cleared 510(K)
K
11
3136
21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)
2
Cleared 510(K)
K
10
3554
METRON-CP/MD
2
Cleared 510(K)
K
11
3226
8MP COLOR LCD MONITOR,RADIFORCE RX840
2
Cleared 510(K)
K
11
3541
CLEARSTART SVM SYSTEM
2
Cleared 510(K)
K
11
3543
ONDEMAND3D
2
Cleared 510(K)
K
11
2480
VIEW 1 IMAGING
2
Cleared 510(K)
K
11
3404
DENTAL 3D PLANNING SOFTWARE
2
Cleared 510(K)
K
11
2930
MOBILE MIM
2
Cleared 510(K)
K
11
2570
CENTRICITY CARDIO IMAGING
2
Cleared 510(K)
K
11
2354
5MP MONOCHROME LCD MONITOR, RADIFORCE GX530
2
Cleared 510(K)
K
11
3029
SYNGO VIA MI WORKFLOWS
2
Cleared 510(K)
K
11
2531
VITREA CT MYOCARDIAL ANALYSIS
2
Cleared 510(K)
K
11
1642
ONCO TRAC MODEL 1, 2, 4
2
Cleared 510(K)
K
11
0596
MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM
2
Cleared 510(K)
K
11
2145
MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2
2
Cleared 510(K)
K
11
1161
PERFSCAPE V2.0
2
Cleared 510(K)
K
11
0765
FXA (TM)
2
Cleared 510(K)
K
10
0784
UC-CARE NAVIGO SYTEM
2
Cleared 510(K)
K
11
2604
21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)
2
Cleared 510(K)
K
11
2466
4MP COLOR LCD MONITOR, RADIFORCERX430
2
Cleared 510(K)
K
11
2974
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
2
Cleared 510(K)
K
11
0919
CARESTREAM PACS
2
Cleared 510(K)
K
11
2439
SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0
2
Cleared 510(K)
K
11
1990
CORONIS 5MP
2
Cleared 510(K)
K
11
2051
LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE
2
Cleared 510(K)
K
11
2530
3DI INCLUDING CSCORE
2
Cleared 510(K)
K
11
2096
IMAGELINK
2
Cleared 510(K)
K
11
1019
SURGIMAP (TM) SPINE
2
Cleared 510(K)
K
11
1641
SURGICASE ORTHOGNATHIC SOFTWARE WIZARD
2
Cleared 510(K)
K
11
1496
21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR
2
Cleared 510(K)
K
11
1989
CORONIS FUSION 4MP DL
2
Cleared 510(K)
K
11
1833
VIRTUE
2
Cleared 510(K)
K
11
1731
MOLECULAR BREAST IMAGING SOFTWARE
2
Cleared 510(K)
K
11
1694
ASTRA
2
Cleared 510(K)
K
11
0033
FEEL-DRCS
2
Cleared 510(K)
K
10
1898
R4 ACERT ULTRASOUND REPORTING SYSTEM
2
Cleared 510(K)
K
11
1660
XELIS CARDIAC
2
Cleared 510(K)
K
11
1346
RESOLUTIONMD MOBILE MODEL RMB-MOB-2X
2
Cleared 510(K)
K
11
1613
XELIS FUSION
2
Cleared 510(K)
K
10
3308
AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE
2
Cleared 510(K)
K
10
3181
ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
2
Cleared 510(K)
K
11
1373
CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE
2
Cleared 510(K)
K
11
1991
NIO COLOR 2MP
2
Cleared 510(K)
K
10
2078
RADIOLOGICAL IMAGE PROCESSING SYSTEM
2
Cleared 510(K)
K
11
1945
IMPAX NEXT GENERATION
2
Cleared 510(K)
K
11
1319
IBIS EXPLORER AND MARKUP SOFTWARE
2
Cleared 510(K)
K
11
1245
HEARTNAVIGATOR RELEASE 1
2
Cleared 510(K)
K
11
1892
VITREAVIEW SOFTWARE 6.1
2
Cleared 510(K)
K
11
1804
INTELLISPACE PACS 4.X
2
Cleared 510(K)
K
11
1222
MRI-Q SYSTEM
2
Cleared 510(K)
K
10
3130
XELIS 3D
2
Cleared 510(K)
K
11
0797
COMMUNIFY PACS VIEWER
2
Cleared 510(K)
K
11
0300
SIMPLANT 2011
2
Cleared 510(K)
K
11
0886
CLIO/CLIOSOFT
2
Cleared 510(K)
K
11
1638
IMPAX VOLUME VIEWING
2
Cleared 510(K)
K
11
0414
QLAB 8.1 QUANTIFICATION SOFTWARE
2
Cleared 510(K)
K
11
1237
MD301C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR, L309TY
2
Cleared 510(K)
K
10
3724
10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030)
2
Cleared 510(K)
K
11
0447
ECHOINSIGHT
2
Cleared 510(K)
K
11
1336
EBW NM 2.0
2
Cleared 510(K)
K
10
2534
AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE
2
Cleared 510(K)
K
11
1052
SYNGO NEURO PBV-IR
2
Cleared 510(K)
K
10
3723
SICAT IMPLANT V1.2
2
Cleared 510(K)
K
11
1079
SYNGO.VIA WEB VIEWER
2
Cleared 510(K)
K
11
0430
DOLPHIN IMAGING
2
Cleared 510(K)
K
11
1164
EUNITY
2
Cleared 510(K)
K
11
1102
RADIOVISION
2
Cleared 510(K)
K
11
0875
CENTRICITY PACS
2
Cleared 510(K)
K
11
0573
READY VIEW
2
Cleared 510(K)
K
11
0834
AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION
2
Cleared 510(K)
K
11
1024
JETPACK 2.0
2
Cleared 510(K)
K
11
0139
CURVE IMAGE
2
Cleared 510(K)
K
11
0844
SYMBIA.NET
2
Cleared 510(K)
K
10
3565
MEDVOXEL HEARTPRO SOFTWARE APPLICATION
2
Cleared 510(K)
K
11
0667
IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS
2
Cleared 510(K)
K
11
0595
4D SONO-SCAN 1.0
2
Cleared 510(K)
K
11
0186
SYNAPSE 3D LIVER ANALYSIS
2
Cleared 510(K)
K
11
0494
SYNGO MBF
2
Cleared 510(K)
K
11
0332
CLEARCANVAS RIS / PACS
2
Cleared 510(K)
K
10
3546
AYCAN WORKSTATION OSIRIX PRO
2
Cleared 510(K)
K
11
0108
MODALIXX
2
Cleared 510(K)
K
10
3720
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
2
Cleared 510(K)
K
11
0511
E4D COMPASS
2
Cleared 510(K)
K
10
3480
THORACIC VCAR
2
Cleared 510(K)
K
10
3792
BARCO MAMMO TOMOSYNTHESIS
2
Cleared 510(K)
K
10
3687
SYNAPSE 3D CEREBRAL ANALYSIS
2
Cleared 510(K)
K
10
3458
VIEWPOINT 6
2
Cleared 510(K)
K
10
3679
AXIS PACS, HMS PACS
2
Cleared 510(K)
K
10
3576
MIM 5.2 (BRACHY)
2
Cleared 510(K)
K
10
3761
VISUALIZE: VASCULAR
2
Cleared 510(K)
K
10
3785
MOBILE MIM
2
Cleared 510(K)
K
10
1842
ACIES
2
Cleared 510(K)
K
10
1398
STEREOS WORKSTATION
2
Cleared 510(K)
K
10
3385
SECURVIEW DX DIAGNOSTIC WORKSTATION
2
Cleared 510(K)
K
11
0071
COR ANALYZER
2
Cleared 510(K)
K
10
3465
SYNAPSE 3D CARDIAC TOOLS
2
Cleared 510(K)
K
11
0077
NEUCOLONCARE
2
Cleared 510(K)
K
11
0040
OMNIVISION
2
Cleared 510(K)
K
10
3815
Q-STATION
2
Cleared 510(K)
K
10
3182
TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
2
Cleared 510(K)
K
10
3475
SPINEANALYER MODEL SAPOC
2
Cleared 510(K)
K
10
0372
SAFECT MODEL VER 1.0
2
Cleared 510(K)
K
10
0837
PACENTRIC CONNECT, TRAVELER AND WEB
2
Cleared 510(K)
K
10
2849
ACCULMAING
2
Cleared 510(K)
K
09
2728
20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A)
2
Cleared 510(K)
K
10
1654
IMPROVIS IMAGING SYSTEM
2
Cleared 510(K)
K
10
1707
FULACCESS MODEL 1.0
2
Cleared 510(K)
K
10
2435
BEYONDIMAGE WORKSTATION
2
Cleared 510(K)
K
10
2000
IMAGYS
2
Cleared 510(K)
K
10
2556
VOLPARA, VERSION 1.3
2
Cleared 510(K)
K
10
1166
4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ
2
Cleared 510(K)
K
10
2150
SYNGO DYNAMICS, VERSION 9.0
2
Cleared 510(K)
K
10
1324
GE ECHOPAC MODEL BT10
2
Cleared 510(K)
K
10
2687
MIRADA RT
2
Cleared 510(K)
K
10
2684
XELIS DENTAL
2
Cleared 510(K)
K
10
1311
EP NAVIGATOR R3
2
Cleared 510(K)
K
10
1697
ENSITE VERISMO SEGMENTATION TOOL V.2.0
2
Cleared 510(K)
K
10
0793
UROSTATION 3D PROSTATE SUITE
2
Cleared 510(K)
K
10
1342
OSIRIX MD
2
Cleared 510(K)
K
09
3269
PROCEDURE REHEARSAL STUDIO
2
Cleared 510(K)
K
10
2148
CURIEPACS (DICOM PACS SOFTWARE)
2
Cleared 510(K)
K
10
1749
SYNGO TRUED SOFTWARE
2
Cleared 510(K)
K
09
0947
21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)
2
Cleared 510(K)
K
10
1666
SYNGO. PLAZA VA20A
2
Cleared 510(K)
K
10
1279
CORRIDOR4DM V2010 MODEL: V2010
2
Cleared 510(K)
K
10
1662
SYNAPSE 3D BASIC TOOLS
2
Cleared 510(K)
K
09
2328
MED-SEG, MODEL BTMS 1000
2
Cleared 510(K)
K
10
1796
PACSMATE MMD-5201M MONITOR
2
Cleared 510(K)
K
10
1228
MIRADA XD
2
Cleared 510(K)
K
09
3197
CORONIS FUSION 10MP, MODEL MDCG-10130
2
Cleared 510(K)
K
09
2915
CEDARA WEBACCESS, MODEL: 2.4
2
Cleared 510(K)
K
10
0619
SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827
2
Cleared 510(K)
K
10
0292
CAAS QVA 3D, CAAS QCA 3D
2
Cleared 510(K)
K
09
4064
ILUMA VISION MODEL VERSION 2.2
2
Cleared 510(K)
K
10
0881
SYNAPSE OBLIQUUS MIP/MPR/FUSION
2
Cleared 510(K)
K
10
0335
ORS VISUAL
2
Cleared 510(K)
K
10
0236
STAIR SYSTEMS PACS & DICOM VIEWER
2
Cleared 510(K)
K
09
3603
STORM-BASE 2.0
2
Cleared 510(K)
K
09
2363
SOFTVIEW, MODEL 2.01
2
Cleared 510(K)
K
09
1631
ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW
2
Cleared 510(K)
K
09
2427
SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION)
2
Cleared 510(K)
K
10
0094
CARESTREAM IMAGE SUITE
2
Cleared 510(K)
K
09
3480
CUATTRO UNOMD
2
Cleared 510(K)
K
09
0050
STEREOS WORKSTATION
2
Cleared 510(K)
K
09
3612
SYNGO.PLAZA
2
Cleared 510(K)
K
09
2613
COLOR LCD MONITOR, MODEL RADIFORCE RS210
2
Cleared 510(K)
K
09
2842
ECHOPLAQUE
2
Cleared 510(K)
K
09
3621
SYNGO.PET&CT ONCOLOGY
2
Cleared 510(K)
K
09
3444
EXAPACS
2
Cleared 510(K)
K
09
3703
3DI
2
Cleared 510(K)
K
09
3982
XELERIS 3 PROCESSING AND REVIEW WORKSTATION
2
Cleared 510(K)
K
09
3355
PCR ELEVA 1.2
2
Cleared 510(K)
K
09
3090
GALILEOS IMPLANT, VERSION 1.7
2
Cleared 510(K)
K
09
3672
AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION
2
Cleared 510(K)
K
09
3117
DIGITAL LIGHTBOX
2
Cleared 510(K)
K
09
1364
DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4
2
Cleared 510(K)
K
09
2125
PRESIDIO PACS
2
Cleared 510(K)
K
09
3247
MEDSYNAPSE PACS SOFTWARE
2
Cleared 510(K)
K
09
2639
INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP
2
Cleared 510(K)
K
09
3423
LUNGPOINT PROCEDURE PLANNING
2
Cleared 510(K)
K
09
2741
COLOR LCD MONITOR, MODEL RADIFORCE MX241W
2
Cleared 510(K)
K
09
2954
CADSTREAM VERSION 5
2
Cleared 510(K)
K
09
3234
INTEGRATED REGISTRATION
2
Cleared 510(K)
K
09
2581
MITS DICOM GATEWAY AND IMAGE MANAGER
2
Cleared 510(K)
K
09
2949
IMAGEGRID RADIOLOGY VIEWER SYSTEM
2
Cleared 510(K)
K
09
2204
PMD VIEWER
2
Cleared 510(K)
K
09
2067
ABVS WORKPLACE
2
Cleared 510(K)
K
09
2134
STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS)
2
Cleared 510(K)
K
09
2519
SYNGO.X
2
Cleared 510(K)
K
09
2102
NORDICBRAINEX SOFTWARE, VERSION 1.0
2
Cleared 510(K)
K
09
2235
BEYONDIMAGE WORKSTATION
2
Cleared 510(K)
K
09
2081
QXLINK
2
Cleared 510(K)
K
09
1274
CORONIS 5MP HD, MODEL MDMG 5121
2
Cleared 510(K)
K
09
1687
PACSMATE, MODEL MMD-4300C/MMD-4300CX
2
Cleared 510(K)
K
08
3658
PACS PLUS 5TH EDITION
2
Cleared 510(K)
K
09
1262
MR CARDIAC FUNCTION ANALYSIS
2
Cleared 510(K)
K
09
1001
MYRIAN 1.4
2
Cleared 510(K)
K
09
0668
VISION TOOLS
2
Cleared 510(K)
K
08
3520
INTELEPACS, MODEL VERSION 3.X.X
2
Cleared 510(K)
K
09
1032
CERNER PROVISION WORKSTATION (VERSION 2.5)
2
Cleared 510(K)
K
09
0431
DEXIS SOFTWARE
2
Cleared 510(K)
K
09
0546
MODIFICATION TO NORDICICE SOFTWARE
2
Cleared 510(K)
K
09
1498
VITREA ENDOVASCULAR STENT PLANNING SOFTWARE
2
Cleared 510(K)
K
09
1368
R2 DIGITALNOW HD(DIGITALNOW HD)
2
Cleared 510(K)
K
09
0461
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0
2
Cleared 510(K)
K
09
0155
CAAS MR FLOW 1.0
2
Cleared 510(K)
K
09
1373
SYNGO TRUED
2
Cleared 510(K)
K
08
3327
SYNGOCIRCULATION DYNAMICPET, VERSION 1.0
2
Cleared 510(K)
K
09
1286
SYNGO US WORKPLACE
2
Cleared 510(K)
K
09
0833
SEGMENT
2
Cleared 510(K)
K
09
1172
NIO 2MP (MDNG-2121)
2
Cleared 510(K)
K
09
1160
LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
2
Cleared 510(K)
K
09
0607
BLUE SKY BIO PLAN, VERSION .38
2
Cleared 510(K)
K
09
0603
BARCO 5MP MAMMO, MODEL MDMG-5221
2
Cleared 510(K)
K
09
0732
NIO COLOR 3MP AND MDNC-3121
2
Cleared 510(K)
K
09
0218
MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ
2
Cleared 510(K)
K
09
0215
MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL
2
Cleared 510(K)
K
08
3910
VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER
2
Cleared 510(K)
K
09
0223
ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024
2
Cleared 510(K)
K
08
3446
CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING
2
Cleared 510(K)
K
09
0649
VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE
2
Cleared 510(K)
K
08
1168
BRIT PACS SYSTEMS
2
Cleared 510(K)
K
09
0481
DEMASQ IMAGING SPFTWARE DEVICE
2
Cleared 510(K)
K
09
0552
UROCARE
2
Cleared 510(K)
K
09
0095
LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
2
Cleared 510(K)
K
09
0295
BODYVIZ, MODEL 100
2
Cleared 510(K)
K
08
3182
DATACOM DC PACS
2
Cleared 510(K)
K
08
3691
BONEVUE
2
Cleared 510(K)
K
08
2623
VISIX IMAGING
2
Cleared 510(K)
K
08
2693
RESOLUTIONMD, RELEASE 2.1
2
Cleared 510(K)
K
08
3491
NEUROSCAPE
2
Cleared 510(K)
K
08
3740
MAMMODIAGNOST VU
2
Cleared 510(K)
K
09
0119
SICAT IMPLANT
2
Cleared 510(K)
K
08
1556
CADSTREAM, VERSION 5.0
2
Cleared 510(K)
K
09
0045
COLOR LCD MONITOR, RADIFORCE RX320
2
Cleared 510(K)
K
08
3618
PACS SCAN
2
Cleared 510(K)
K
08
3916
LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD
2
Cleared 510(K)
K
08
3149
ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
2
Cleared 510(K)
K
08
3907
MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG
2
Cleared 510(K)
K
08
3332
MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK
2
Cleared 510(K)
K
08
2808
IMAGESVR PACS
2
Cleared 510(K)
K
08
2526
CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)
2
Cleared 510(K)
K
08
3673
CARESTREAM PACS, MODEL CARESTREAM PACS VII
2
Cleared 510(K)
K
08
3348
IMAGE-ARENA APPLICATIONS
2
Cleared 510(K)
K
08
3084
CT BRAIN PERFUSION FOR ZIOSTATION
2
Cleared 510(K)
K
08
3555
PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION
2
Cleared 510(K)
K
08
2269
VISAGE PACS, VERSION 6.0/CS 3.1
2
Cleared 510(K)
K
08
2607
MRI-PLAQUE VIEW, VERSION 1.1.2003
2
Cleared 510(K)
K
08
2441
NORDICICE SOFTWARE
2
Cleared 510(K)
K
08
2990
INFINITT XELIS
2
Cleared 510(K)
K
08
2628
CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23
2
Cleared 510(K)
K
08
2240
SNTRYPACS
2
Cleared 510(K)
K
08
3018
CENTRICITY PACS WEB DIAGNOSTIC
2
Cleared 510(K)
K
08
2430
SYNGO IMAGING XS
2
Cleared 510(K)
K
08
2706
INFINITT CARDIOLOGY PACS
2
Cleared 510(K)
K
08
2493
MEDICAL DISPLAY, MD205MG-1
2
Cleared 510(K)
K
08
2135
SHOWCASE
2
Cleared 510(K)
K
08
2336
XR-EXPRESS
2
Cleared 510(K)
K
08
2684
4D VIEWER RADIOLOGY, MODEL USWP-100A
2
Cleared 510(K)
K
08
2663
COLOR LCD MONITOR
2
Cleared 510(K)
K
08
2510
IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0
2
Cleared 510(K)
K
08
1987
UNISYN IMAGE FUSION, VERSION 1.0
2
Cleared 510(K)
K
08
1985
AW SERVER
2
Cleared 510(K)
K
08
2596
ULTRAEXTEND USWS-900A
2
Cleared 510(K)
K
08
2228
PLANISIGHT LINASYS
2
Cleared 510(K)
K
08
1948
RAYPAX SYSTEM
2
Cleared 510(K)
K
08
1792
SPY ANALYSIS TOOLKIT, MODEL SA9000
2
Cleared 510(K)
K
08
2386
INREACH PLANNING LAPTOP
2
Cleared 510(K)
K
08
2483
QUANTRA
2
Cleared 510(K)
K
08
1945
21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A)
2
Cleared 510(K)
K
08
1656
VISUALASE THERMAL THERAPY SYSTEM
2
Cleared 510(K)
K
08
2496
PACSMATE MMD-3213M MONITOR
2
Cleared 510(K)
K
08
2144
AMICAS PACS, VERSION 6.0
2
Cleared 510(K)
K
08
1357
5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9)
2
Cleared 510(K)
K
08
0196
Z3D CONTRAST ACUITY
2
Cleared 510(K)
K
08
2341
DSA 2000EX
2
Cleared 510(K)
K
08
0529
STEREOS WORKSTATION
2
Cleared 510(K)
K
08
1215
VOLUMINA
2
Cleared 510(K)
K
08
2318
CENTRICITY PACS IW
2
Cleared 510(K)
K
08
1672
C-INSIGHT
2
Cleared 510(K)
K
08
1752
EDGE PACS
2
Cleared 510(K)
K
08
2041
FIATLUX VISUALIZE
2
Cleared 510(K)
K
08
1630
MAMMO WORKSTATION
2
Cleared 510(K)
K
08
1976
IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
2
Cleared 510(K)
K
08
1512
STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE
2
Cleared 510(K)
K
08
1402
SIMPLANT ORTHO ; VISTADENT 3D
2
Cleared 510(K)
K
08
0905
QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI
2
Cleared 510(K)
K
08
1843
ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
2
Cleared 510(K)
K
08
1734
SYNGO IMAGING (VERSION V31)
2
Cleared 510(K)
K
08
1076
VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE
2
Cleared 510(K)
K
08
1262
DC NEURO
2
Cleared 510(K)
K
08
1469
SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2
2
Cleared 510(K)
K
08
1304
ALZ WEB PACS, VERSION 1.0
2
Cleared 510(K)
K
08
1242
21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)
2
Cleared 510(K)
K
08
1308
FUJIFILM FCR VIEW, MODEL CR-VW674
2
Cleared 510(K)
K
08
1056
21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A)
2
Cleared 510(K)
K
08
1055
21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A)
2
Cleared 510(K)
K
08
0951
19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A
2
Cleared 510(K)
K
08
0952
15-INCH (38 CM) COLOR LCD MONITOR CDL1576A
2
Cleared 510(K)
K
08
1347
ILUMA VISION
2
Cleared 510(K)
K
07
2258
BI-RADS COMPANION
2
Cleared 510(K)
K
08
1109
CORONIS 5MP MAMMO SL, MODEL MDMG 6121
2
Cleared 510(K)
K
08
1093
3-D IMAGING WORKSTATION
2
Cleared 510(K)
K
08
0890
SMARTSPOT PRIMAX
2
Cleared 510(K)
K
08
1018
SYNGO DYNAMICS VERSION 7.0
2
Cleared 510(K)
K
07
3358
LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A
2
Cleared 510(K)
K
08
0351
DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI
2
Cleared 510(K)
K
07
2728
SYNGO MULTIMODALITY WORKPLACE
2
Cleared 510(K)
K
08
0961
NM APPLICATION SUITE
2
Cleared 510(K)
K
08
0608
DIGITAL LIGHTBOX
2
Cleared 510(K)
K
07
3449
SURGICASE
2
Cleared 510(K)
K
08
0770
IMAGENMD WITH IMAGENQ
2
Cleared 510(K)
K
08
0325
IGROK
2
Cleared 510(K)
K
07
3468
MIMICS
2
Cleared 510(K)
K
08
0457
COLOR LCD MONITOR, MODEL RADIFORCE RX211
2
Cleared 510(K)
K
07
3714
TRAUMACAD VERSION 2.0
2
Cleared 510(K)
K
07
3176
KANTERON DICOM STATION (KDS), MODEL 3.0
2
Cleared 510(K)
K
07
3526
AMICAS VISION SERIES PACS, MODEL 5.5
2
Cleared 510(K)
K
08
0422
5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520
2
Cleared 510(K)
K
07
3062
OMNI-VUE SYSTEM
2
Cleared 510(K)
K
07
3418
SYNGO IMAGING CCF VA10A
2
Cleared 510(K)
K
08
0333
IMAGEGRID
2
Cleared 510(K)
K
08
0290
XVIEWNET
2
Cleared 510(K)
K
08
0334
INSTARAD
2
Cleared 510(K)
K
08
0320
PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300
2
Cleared 510(K)
K
07
3704
I-DIXEL
2
Cleared 510(K)
K
07
2821
VITREA 4DCT
2
Cleared 510(K)
K
07
3194
CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS
2
Cleared 510(K)
K
07
3007
CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL
2
Cleared 510(K)
K
07
1794
15M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2123A (MS51I2)
2
Cleared 510(K)
K
07
2653
3VISEON/SURGERY
2
Cleared 510(K)
K
07
2875
NIO 5MP DISPLAY, MODEL E5620
2
Cleared 510(K)
K
07
3292
MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM
2
Cleared 510(K)
K
08
0013
REGISTRATION AND FUSION
2
Cleared 510(K)
K
07
3169
SCIMAGE PICOMENTERPRISE
2
Cleared 510(K)
K
07
3306
XORANCONNECT
2
Cleared 510(K)
K
07
3448
MEDICAL DISPLAY, MD205MG
2
Cleared 510(K)
K
07
3259
XIDF-100A/B1 IMAGE PROCESSOR
2
Cleared 510(K)
K
07
3340
COLOR LCD MONITOR, FLEXSCAN MX300W
2
Cleared 510(K)
K
07
3205
NIO 5MP, MODEL MDNG-5121
2
Cleared 510(K)
K
07
3272
WORKSTATIONONE BREAST IMAGING WORKSTATION
2
Cleared 510(K)
K
07
2637
DIVO
2
Cleared 510(K)
K
07
3271
ORTHOGON
2
Cleared 510(K)
K
07
2986
INTEGRADWEB PACS SYSTEM
2
Cleared 510(K)
K
07
2952
GE ECHOPAC
2
Cleared 510(K)
K
07
2960
CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET
2
Cleared 510(K)
K
07
2972
MEDSTREAMING MEDICAL OFFICE SOFTWARE
2
Cleared 510(K)
K
07
2532
TRUEPIX LCD MEDICAL DISPLAY MONITOR, MODELS TX-5M, TX-3M, TX-2M
2
Cleared 510(K)
K
07
2665
SUNIRAY 5.2
2
Cleared 510(K)
K
07
1964
MIM 4.1 (SEASTAR)
2
Cleared 510(K)
K
07
2242
COR ANALYZER II, MODEL V1.7
2
Cleared 510(K)
K
07
1584
OASIS RELEASE 1.0
2
Cleared 510(K)
K
07
2205
VISAGE PACS/CS, RELEASE VERSION 5.0
2
Cleared 510(K)
K
07
1492
FIRSTVIEW
2
Cleared 510(K)
K
07
1894
XEBRA DICOM IMAGE BROWSER
2
Cleared 510(K)
K
07
2066
1.3M MONOCHROME LCD MONITOR MDL1908A
2
Cleared 510(K)
K
07
2065
20.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2)
2
Cleared 510(K)
K
07
1636
CODIAGNOSTIX (R) 5.72
2
Cleared 510(K)
K
06
3066
AXIS-V MONOCHROME 5 MP DISPLAY
2
Cleared 510(K)
K
07
1972
ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS
2
Cleared 510(K)
K
07
1950
SYNGO TRUED
2
Cleared 510(K)
K
07
1602
IMAGIC V2.0
2
Cleared 510(K)
K
07
1166
UNIWEB, VERSION 5.0
2
Cleared 510(K)
K
07
1599
EASYGUIDE
2
Cleared 510(K)
K
07
1436
REGIUS UNITEA
2
Cleared 510(K)
K
06
2878
EZPACS, VERSION 3.0
2
Cleared 510(K)
K
07
1297
IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)
2
Cleared 510(K)
K
07
1232
IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS
2
Cleared 510(K)
K
07
1241
LMS-LIVER
2
Cleared 510(K)
K
07
1086
RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0
2
Cleared 510(K)
K
07
1362
VITAL CONNECT 4.1
2
Cleared 510(K)
K
07
1331
VITREA VERSION 4.0
2
Cleared 510(K)
K
06
3269
5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC
2
Cleared 510(K)
K
07
1114
SYNGO IMAGING (VERSION V30)
2
Cleared 510(K)
K
07
1054
RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4
2
Cleared 510(K)
K
07
0831
VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION
2
Cleared 510(K)
K
07
0868
LMS-LUNG/TRACK
2
Cleared 510(K)
K
07
1000
MYRIAN
2
Cleared 510(K)
K
07
0755
INTERWORKS
2
Cleared 510(K)
K
07
0726
NIO COLOR 3MP AND MDNC 3120
2
Cleared 510(K)
K
07
0713
IMPLANT LOCATION SOFTWARE-T
2
Cleared 510(K)
K
06
3391
SAPHENEIA CLARITY
2
Cleared 510(K)
K
07
0618
DICOMPACS, MODEL 5
2
Cleared 510(K)
K
07
0606
VISIO+CD VIEWER# KPSCDVE01
2
Cleared 510(K)
K
07
0954
PATIENTGALLERY IMAGING SOFTWARE
2
Cleared 510(K)
K
07
0397
DGSCOPE, RELEASE 1.0
2
Cleared 510(K)
K
07
0683
MIRAGE CEDARS OPTION
2
Cleared 510(K)
K
07
0803
INVIVODENTAL
2
Cleared 510(K)
K
07
0796
CHILI PACS
2
Cleared 510(K)
K
07
0792
QLAB QUANTIFICATION
2
Cleared 510(K)
K
07
0394
CERNER PROVISION WORKSTATION
2
Cleared 510(K)
K
07
0205
ZIOSTATION
2
Cleared 510(K)
K
06
2621
NIO 5MP-21 AND MDNG-5121 CB
2
Cleared 510(K)
K
07
0464
ONDEMAND3D
2
Cleared 510(K)
K
07
0370
21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2122A
2
Cleared 510(K)
K
07
0226
CARDIOCT
2
Cleared 510(K)
K
07
0089
SYNTERMED LIVE
2
Cleared 510(K)
K
07
0248
VELOCITYAIS
2
Cleared 510(K)
K
07
0322
SYNGO DYNAMICS, VERSION 6.0
2
Cleared 510(K)
K
07
0131
RADIFORCE GX220 AND GS220 MONOCHROME LCD MONITORS
2
Cleared 510(K)
K
07
0244
AEGIS
2
Cleared 510(K)
K
07
0122
MONOCHROME LCD MONITOR, MODEL RADIFORCE GX320
2
Cleared 510(K)
K
06
3730
DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0
2
Cleared 510(K)
K
06
3846
EIGEN DSA 2000
2
Cleared 510(K)
K
07
0080
INTELEPACS
2
Cleared 510(K)
K
06
3294
TOPACS
2
Cleared 510(K)
K
06
3548
COR ANALYZER 1, VERSION 1.4
2
Cleared 510(K)
K
06
3439
MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS
2
Cleared 510(K)
K
06
3539
NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1
2
Cleared 510(K)
K
06
3826
SYNGO MI APPLICATIONS 2007A
2
Cleared 510(K)
K
06
3781
PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE
2
Cleared 510(K)
K
06
3470
AYCAN WORKSTATION OSIRIX
2
Cleared 510(K)
K
06
2905
NIO FUSION 4MP; MDNC 4130
2
Cleared 510(K)
K
06
3628
CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY
2
Cleared 510(K)
K
06
3579
2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC
2
Cleared 510(K)
K
06
3505
VISUALASE ENVISION SOFTWARE SYSTEM
2
Cleared 510(K)
K
06
3392
IMCO-STAT
2
Cleared 510(K)
K
06
3337
OPAL-RAD
2
Cleared 510(K)
K
06
3253
RCHIVE PACS
2
Cleared 510(K)
K
06
3221
MEDWEB ADVANCED 3D WEB PACS
2
Cleared 510(K)
K
06
3200
20.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204)
2
Cleared 510(K)
K
06
3153
NOVAPACS
2
Cleared 510(K)
K
06
3199
21.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2)
2
Cleared 510(K)
K
06
3188
DEL-IMS
2
Cleared 510(K)
K
06
3198
21.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2)
2
Cleared 510(K)
K
06
3197
21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL21