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by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
EAG
Cephalometer
2
Product Code
EAH
Cone, Radiographic, Lead-Lined
1
Product Code
EAP
Unit, X-Ray, Intraoral
2
Product Code
EHB
Collimator, X-Ray
1
Product Code
EHD
Unit, X-Ray, Extraoral With Timer
2
Product Code
MUH
System, X-Ray, Extraoral Source, Digital
2
Product Code
EAM
Screen, Intensifying, Radiographic
1
Product Code
EGT
Controller, Temperature, Radiographic
2
Product Code
EGW
Dryer, Film, Radiographic
2
Product Code
EGY
Processor, Radiographic-Film, Automatic, Dental
2
Product Code
HBK
Chair, Pneumoencephalographic
2
Product Code
ITX
Transducer, Ultrasonic, Diagnostic
2
Product Code
ITY
Assembly, Tube Housing, X-Ray, Diagnostic
1
Product Code
IWN
Cassette, Measurement, Ardran-Crooks
1
Product Code
IWY
Holder, Head, Radiographic
1
Product Code
IWZ
Film, Radiographic
1
Product Code
IXA
Cassette, Radiographic Film
2
Product Code
IXC
Illuminator, Radiographic-Film
1
Product Code
IXD
Source, Calibration, Sealed, Nuclear
1
Product Code
IXF
Test-Pattern, Radiographic
1
Product Code
IXG
Phantom, Anthropomorphic, Radiographic
1
Product Code
IXH
Camera, Focal Spot, Radiographic
1
Product Code
IXJ
Grid, Radiographic
1
Product Code
IXK
System, Imaging, X-Ray, Electrostatic
2
Product Code
IXL
Device, Spot-Film
2
Product Code
IXO
Synchronizer, Ecg / Respirator, Radiographic
1
Product Code
IXQ
Table, Radiographic, Stationary Top
2
Product Code
IXR
Table, Radiographic, Tilting
2
Product Code
IXW
Processor, Radiographic-Film, Automatic
2
Product Code
IXX
Processor, Cine Film
2
Product Code
IXY
Holder, Radiographic Cassette, Wall-Mounted
1
Product Code
IYB
Tube Mount, X-Ray, Diagnostic
1
Product Code
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
2
Product Code
IYO
System, Imaging, Pulsed Echo, Ultrasonic
2
Product Code
IYP
Phantom, Anthropomorphic, Nuclear
1
Product Code
IYQ
Phantom, Flood Source, Nuclear
1
Product Code
IYT
System, Rebreathing, Radionuclide
2
Product Code
IYW
Scanner, Rectilinear, Nuclear
1
Product Code
IYX
Camera, Scintillation (Gamma)
1
Product Code
IYY
Synchronizer, Electrocardiograph, Nuclear
1
Product Code
IYZ
Bed, Scanning, Nuclear
1
Product Code
IZC
Camera, Positron
1
Product Code
IZD
Probe, Uptake, Nuclear
1
Product Code
IZF
System, X-Ray, Tomographic
2
Product Code
IZG
System, X-Ray, Photofluorographic
2
Product Code
IZH
System, X-Ray, Mammographic
2
Product Code
IZI
System, X-Ray, Angiographic
2
Product Code
IZJ
Camera, X-Ray, Fluorographic, Cine Or Spot
2
Product Code
IZL
System, X-Ray, Mobile
2
Product Code
IZO
Generator, High-Voltage, X-Ray, Diagnostic
1
Product Code
IZP
Programmer, Changer, Film/Cassette, Radiographic
2
Product Code
IZS
Aperture, Radiographic
2
Product Code
IZT
Cone, Radiographic
2
Product Code
IZW
Collimator, Automatic, Radiographic
2
Product Code
IZX
Collimator, Manual, Radiographic
2
Product Code
IZZ
Table, Radiographic, Non-Tilting, Powered
2
Product Code
JAA
System, X-Ray, Fluoroscopic, Image-Intensified
2
Product Code
JAB
System, X-Ray, Fluoroscopic, Non-Image-Intensified
2
Product Code
JAC
System, X-Ray, Film Marking, Radiographic
1
Product Code
JAF
Monitor, Ultrasonic, Nonfetal
2
Product Code
JAG
Illuminator, Radiographic-Film, Explosion-Proof
1
Product Code
JAK
System, X-Ray, Tomography, Computed
2
Product Code
JAM
Scanner, Whole Body, Nuclear
1
Product Code
JAN
Counter, Whole Body, Nuclear
1
Product Code
JAO
Scanner, Fluorescent
2
Product Code
JAR
Phantom, Test-Pattern, Radionuclide
1
Product Code
JWM
System, Tomographic, Nuclear
2
Product Code
KGI
Densitometer, Bone
2
Product Code
KPR
System, X-Ray, Stationary
2
Product Code
KPS
System, Tomography, Computed, Emission
2
Product Code
KPT
Calibrator, Dose, Radionuclide
2
Product Code
KPW
Device, Beam Limiting, X-Ray, Diagnostic
2
Product Code
KPX
Changer, Radiographic Film/Cassette
2
Product Code
KXH
Cradle, Patient, Radiologic
1
Product Code
KXJ
Table, Radiologic
2
Product Code
LEK
Transilluminator (Diaphanoscope)
3
Product Code
LHO
Instrument, Quality-Assurance, Radiologic
1
Product Code
LLZ
System, Image Processing, Radiological
2
Product Code
LMA
Digitizer, Image, Radiological
2
Product Code
LMB
Device, Digital Image Storage, Radiological
1
Product Code
LMC
Camera, Multi Format, Radiological
2
Product Code
LMD
System, Digital Image Communications, Radiological
1
Product Code
K
99
4329
IIVS INTEGRATED IMAGE VIEWING STATION
1
Cleared 510(K)
K
99
2698
STENTOR, PAGEVIEW
1
Cleared 510(K)
K
99
2426
RAYPAX WEB CLINICAL SYSTEM
1
Cleared 510(K)
K
99
2352
ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
1
Cleared 510(K)
K
99
1537
SAMSUNG RAYPAX SYSTEM
1
Cleared 510(K)
K
98
4000
STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
1
Cleared 510(K)
K
97
4707
IMAGEQUEST
1
Cleared 510(K)
K
98
1053
KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW
1
Cleared 510(K)
K
98
0918
JPACS
1
Cleared 510(K)
K
97
4882
DOWNSCAN LT
1
Cleared 510(K)
K
98
0684
VR NETSERVE
1
Cleared 510(K)
K
98
0541
BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY
1
Cleared 510(K)
K
98
0241
NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE
1
Cleared 510(K)
K
98
0220
IISYS PACS SYSTEM
1
Cleared 510(K)
K
97
4130
VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE
1
Cleared 510(K)
K
97
4255
CD-R STATION AND VRS-2000
1
Cleared 510(K)
K
97
4107
KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW)
1
Cleared 510(K)
K
97
4102
MILTRA IMAGING INC., IMAGE VAULT
1
Cleared 510(K)
K
97
3805
IMAGEACCESS SYSTEM
1
Cleared 510(K)
K
97
2701
BARCO MWD 321 MEDICAL WORKSTATION DISPLAY
1
Cleared 510(K)
K
97
3959
OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE
1
Cleared 510(K)
K
97
3793
OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE
1
Cleared 510(K)
K
97
3421
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT}
1
Cleared 510(K)
K
97
2925
ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC
1
Cleared 510(K)
K
97
3239
DICOM 3.0 SOFTWARE VERSION 2.0
1
Cleared 510(K)
K
97
3303
IMATION MODEL 9410 NETWORK INTERFACE
1
Cleared 510(K)
K
97
3131
SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)
1
Cleared 510(K)
K
97
3090
MEDSTATION
1
Cleared 510(K)
K
97
2366
IMNET DICOM NETWORK AGENT
1
Cleared 510(K)
K
97
2191
DIGITIZER DIRECTOR (HSC025-01)
1
Cleared 510(K)
K
97
1347
MEDISURF
1
Cleared 510(K)
K
97
1154
MULTIPICS(ME-977)
1
Cleared 510(K)
K
97
1153
SPLITSCREEN (ME-975)
1
Cleared 510(K)
K
97
0628
GE ADVANTAGE DIGITIZER WORKSTATION
1
Cleared 510(K)
K
97
0652
MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE
1
Cleared 510(K)
K
97
0641
RIS SCANVIEW SYSTEM (RSVS)
1
Cleared 510(K)
K
97
0174
FREEPIX/PIXPACS DICOM/HTTP GATEWAY
1
Cleared 510(K)
K
97
0293
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
1
Cleared 510(K)
K
97
0064
AMICAS WEB/INTRANET IMAGE SERVER
1
Cleared 510(K)
K
96
5161
SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)
1
Cleared 510(K)
K
96
4250
LINX NETWORKING SYSTEM
1
Cleared 510(K)
K
96
3861
LASERSHARE PRINT SPOOLER AND/OR SOFTWARE
1
Cleared 510(K)
K
96
3628
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE
1
Cleared 510(K)
K
96
3592
IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000
1
Cleared 510(K)
K
96
3594
IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)
1
Cleared 510(K)
K
96
2225
VIEWSEND MEDICAL MODEL 1200
1
Cleared 510(K)
K
96
1023
AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR)
1
Cleared 510(K)
K
96
2699
RADWORKS MEDICAL IMAGING SOFTWARE
1
Cleared 510(K)
K
96
1689
INFINET
1
Cleared 510(K)
K
96
1753
SHARED VISION(PART NUMBER SV 0015)
1
Cleared 510(K)
K
96
0911
NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE
1
Cleared 510(K)
K
96
0382
KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER
1
Cleared 510(K)
K
95
4567
RTI MEDICAL
1
Cleared 510(K)
K
96
0809
PHILIPS SITE VIEW WORKSTATION
1
Cleared 510(K)
K
95
4691
ACCESS RADIOLOGY TELERADIOLOGY IMAGE ACQUISITION & DISTRIBUTION SYSTEM
1
Cleared 510(K)
K
95
4172
X-RAY VISIONS
1
Cleared 510(K)
K
95
5708
COMPUMED DICON CLIENT
1
Cleared 510(K)
K
95
4071
IDXVIEW
1
Cleared 510(K)
K
95
4479
DICOMVIEW
1
Cleared 510(K)
K
95
5000
REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE
1
Cleared 510(K)
K
95
0513
ARCHIVEMANAGER
1
Cleared 510(K)
K
95
4008
REDI-VU SYSTEMS (SEND & RECEIVE)
1
Cleared 510(K)
K
95
3552
SIENET SPI SPOOLER
1
Cleared 510(K)
K
95
3371
LUMISYS DICOM TOOKLIT
1
Cleared 510(K)
K
95
3514
COURIER II
1
Cleared 510(K)
K
95
3398
UNISCAN
1
Cleared 510(K)
K
95
3080
DIGITAL IMAGING SYSTEM INTERFACE
1
Cleared 510(K)
K
95
3163
QUICK READ 2000 (QR2000)
1
Cleared 510(K)
K
95
2914
STAR TECHNOLOGIES, INC. FILM IMAGE SCAN SYSTEM
1
Cleared 510(K)
K
95
2533
SIENET DICOM GATEWAY
1
Cleared 510(K)
K
95
1175
MEDICAL IMAGING INFORMATION AND CAPTURE SYSTEM (MIICS)
1
Cleared 510(K)
K
95
0413
MEDIPACS
1
Cleared 510(K)
K
95
2484
MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A
1
Cleared 510(K)
K
94
3994
PACS EQUIPMENT
1
Cleared 510(K)
K
95
0431
LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM
1
Cleared 510(K)
K
95
0699
PREVIEW TELEIMAGING SYSTEM
1
Cleared 510(K)
K
95
0343
HYPERPACS PACS AND TELERAFIOLOGY SYSTEM
1
Cleared 510(K)
K
94
4322
AT&T IMAGE SOLUTIONS PICASSO STILL-IMAGE PHONE SYSTEM
1
Cleared 510(K)
K
92
5964
IMAGE TRANSPORT SERIES III
1
Cleared 510(K)
K
94
0859
PACSPRO I
1
Cleared 510(K)
K
94
4771
INTRASCAN II
1
Cleared 510(K)
K
94
4130
RIT 531 TELERADIOLOGY/ PAC SYSTEM
1
Cleared 510(K)
K
94
1224
LENZAR REMOTE ACQUISITION SYSTEM
1
Cleared 510(K)
K
94
2861
MEDVISION ENVIROMENT/MEDVISION 2.0
1
Cleared 510(K)
K
94
3383
IMAGING WORKBENCH
1
Cleared 510(K)
K
94
3158
AD/V IMAGEPLEX(TM)
1
Cleared 510(K)
K
94
2917
ULTRAPRO WORKSTATION
1
Cleared 510(K)
K
94
0423
NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE
1
Cleared 510(K)
K
94
1203
MEDICAL IMAGING WORKSTATION II (MIW II)
1
Cleared 510(K)
K
94
1086
PACSPRO II
1
Cleared 510(K)
K
94
0408
REMOTE CONSOLE
1
Cleared 510(K)
K
93
6153
3M 1156 MULTI-INPUT SYSTEM
1
Cleared 510(K)
K
93
6116
KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS
1
Cleared 510(K)
K
93
5103
VISIONLINK ACR-NEMA CONVERSION UTILITIES
1
Cleared 510(K)
K
93
4386
IMPAX 5000
1
Cleared 510(K)
K
93
0500
MAXIVIEW DIAGNOSTIC WORKSTATION
1
Cleared 510(K)
K
92
6315
PRACTICE PARTNER
1
Cleared 510(K)
K
93
1186
PHOTOPHONE MULTIVIEW
1
Cleared 510(K)
K
93
1795
TELERAD STAT
1
Cleared 510(K)
K
93
3409
IMPAX 1000
1
Cleared 510(K)
K
93
3103
DIGITAL IMAGE COMMUNICATIONS SYSTEM
1
Cleared 510(K)
K
93
3098
MEDICAL IMAGE MANAGEMENT SYSTEM/X-RAY TERMINAL
1
Cleared 510(K)
K
92
5864
COURIER PC
1
Cleared 510(K)
K
93
1292
MULTIVIEW FOR WINDOWS
1
Cleared 510(K)
K
93
1551
KODAK EKTASCAN IMAGELINK SYSTEM (KEIS)
1
Cleared 510(K)
K
92
6098
DIGIRAY
1
Cleared 510(K)
K
93
1060
STATVIEW
1
Cleared 510(K)
K
92
5050
PC TELERADIOLOGY(TM)
1
Cleared 510(K)
K
93
0350
RADMAN IMAGE MANAGMENT SYSTEM
1
Cleared 510(K)
K
93
0997
DOMINATOR RADIOLOGY SYSTEM
1
Cleared 510(K)
K
92
1185
TELEMEDIC TELERADIOLOGY SYSTEM
1
Cleared 510(K)
K
92
5994
RSTAR IMAGE MANAGMENT SYTEM (RSTAR-IMS)
1
Cleared 510(K)
K
92
5929
RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS)
1
Cleared 510(K)
K
92
4178
MEDVISION(TM) IMAGING SOFTWARE
1
Cleared 510(K)
K
92
5284
IMAGESSSHARE 910
1
Cleared 510(K)
K
92
2164
RAYTEL DIGITAL IMAGING SYSTEMS
1
Cleared 510(K)
K
92
5097
VORTECH'S AUTOROUTER (AUTOMATIC IMAGE ROUTING)
1
Cleared 510(K)
K
92
4229
VG-A MIG
1
Cleared 510(K)
K
92
3582
SIENET CAMERA SERVER
1
Cleared 510(K)
K
92
1877
AD/V SPOOLER
1
Cleared 510(K)
K
92
1527
STATVIEW
1
Cleared 510(K)
K
92
0268
3M DIGITAL DISK INTERFACE UNIT
1
Cleared 510(K)
K
92
1278
M-2000 DIAGNOSTIC AND TELERADIOLOGY WORKSTATION
1
Cleared 510(K)
K
92
0310
SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE
1
Cleared 510(K)
K
91
4444
XPR PRINTER REDUNDANCY
1
Cleared 510(K)
K
91
4191
XLP NETWORK PRINTING
1
Cleared 510(K)
K
91
1773
PHILIPS TELESCAN
1
Cleared 510(K)
K
91
1405
KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T
1
Cleared 510(K)
K
90
5199
PACSNET RESEARCH TOOLKIT
1
Cleared 510(K)
K
90
0935
DU PONT LINX LASER IMAGER W/THE LINX NETWORKING
1
Cleared 510(K)
K
89
6095
IMAGES-ON-CALL TELERADIOLOGY SYSTEM
1
Cleared 510(K)
K
90
0227
MVP (MULTI-VENDOR PROTOCOL CONVERTOR)
1
Cleared 510(K)
K
89
5209
FILMFAX
1
Cleared 510(K)
K
89
1192
MEDI-TRACE THERMAL VIDEO FILM PAPER
1
Cleared 510(K)
K
88
4434
VORTECH'S MEDICAL IMAGING GATEWAY
1
Cleared 510(K)
K
88
2754
REPORT AND IMAGE MANAGEMENT SYSTEM
1
Cleared 510(K)
K
87
3121
GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS)
1
Cleared 510(K)
K
87
1984
KODAK EKTASCAN IMAGE TRANS. T1/R1 & P1 SOFTWARE
1
Cleared 510(K)
K
86
2158
AVP TELEIMAGING SYSTEM
1
Cleared 510(K)
K
86
2744
TELERADIOGRAPHY SYSTEM
1
Cleared 510(K)
K
86
2715
COMMVIEW SYSTEM
1
Cleared 510(K)
K
85
0417
INTERFACE MODULES IM 1000 IMAGE COMMUNI-NETWORK
1
Cleared 510(K)
LNH
System, Nuclear Magnetic Resonance Imaging
2
Product Code
LNI
System, Nuclear Magnetic Resonance Spectroscopic
2
Product Code
LQA
Media, Reusable Image
1
Product Code
MOS
Coil, Magnetic Resonance, Specialty
2
Product Code
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
2
Product Code
MUA
Bone Sonometer
2
Product Code
MUE
Full Field Digital, System, X-Ray, Mammographic
2
Product Code
MUI
Media, Coupling, Ultrasound
2
Product Code
MWP
Cabinet, X-Ray System
2
Product Code
MYN
Analyzer, Medical Image
2
Product Code
NCS
System, Imaging, Holography, Acoustic
2
Product Code
NWE
Colon Computed Tomography System, Computer Aided Detection
2
Product Code
OAS
X-Ray, Tomography, Computed, Dental
2
Product Code
OEB
Lung Computed Tomography System, Computer-Aided Detection
2
Product Code
OII
Arthrogram Tray
2
Product Code
OIJ
Biopsy Needle Guide Kit
2
Product Code
OIK
Radiology Dental Tray
2
Product Code
OIL
Discography Kit
2
Product Code
OIM
Mri Disposable Kit
2
Product Code
OIO
Radiographic Contrast Tray
2
Product Code
OIP
Radiology-Diagnostic Kit
2
Product Code
OMJ
Chest X-Ray Computer Aided Detection
2
Product Code
OQQ
Diagnostic Ultrasonic Transducer, Robotic
2
Product Code
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
2
Product Code
OWB
Interventional Fluoroscopic X-Ray System
2
Product Code
OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
2
Product Code
PGY
Display, Diagnostic Radiology
2
Product Code
POK
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
2
Product Code
QAS
Radiological Computer-Assisted Triage And Notification Software
2
Product Code
QFM
Radiological Computer-Assisted Prioritization Software For Lesions
2
Product Code
QHA
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
2
Product Code
QHX
Fluoroscopic X-Ray Image Intensifier
1
Product Code
QHY
Solid State Fluoroscopic X-Ray Imager
2
Product Code
QIH
Automated Radiological Image Processing Software
2
Product Code
QKB
Radiological Image Processing Software For Radiation Therapy
2
Product Code
RCC
C-Arm Fluoroscopic X-Ray System
2
Product Code
QTZ
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
2
Product Code
QXL
Cabinet, Emission Computed Tomography System
2
Product Code
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
RA
/
subpart-b—diagnostic-devices
/
LMD
/
K925864
View Source
COURIER PC
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K925864
510(k) Type
Traditional
Applicant
SHORELINE BUSINESS CONSULTING
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/20/1993
Days to Decision
305 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
K
99
4329
IIVS INTEGRATED IMAGE VIEWING STATION
K
99
2698
STENTOR, PAGEVIEW
K
99
2426
RAYPAX WEB CLINICAL SYSTEM
K
99
2352
ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
K
99
1537
SAMSUNG RAYPAX SYSTEM
K
98
4000
STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
K
97
4707
IMAGEQUEST
K
98
1053
KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW
K
98
0918
JPACS
K
97
4882
DOWNSCAN LT
K
98
0684
VR NETSERVE
K
98
0541
BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY
K
98
0241
NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE
K
98
0220
IISYS PACS SYSTEM
K
97
4130
VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE
K
97
4255
CD-R STATION AND VRS-2000
K
97
4107
KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW)
K
97
4102
MILTRA IMAGING INC., IMAGE VAULT
K
97
3805
IMAGEACCESS SYSTEM
K
97
2701
BARCO MWD 321 MEDICAL WORKSTATION DISPLAY
K
97
3959
OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE
K
97
3793
OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE
K
97
3421
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT}
K
97
2925
ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC
K
97
3239
DICOM 3.0 SOFTWARE VERSION 2.0
K
97
3303
IMATION MODEL 9410 NETWORK INTERFACE
K
97
3131
SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)
K
97
3090
MEDSTATION
K
97
2366
IMNET DICOM NETWORK AGENT
K
97
2191
DIGITIZER DIRECTOR (HSC025-01)
K
97
1347
MEDISURF
K
97
1154
MULTIPICS(ME-977)
K
97
1153
SPLITSCREEN (ME-975)
K
97
0628
GE ADVANTAGE DIGITIZER WORKSTATION
K
97
0652
MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE
K
97
0641
RIS SCANVIEW SYSTEM (RSVS)
K
97
0174
FREEPIX/PIXPACS DICOM/HTTP GATEWAY
K
97
0293
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
K
97
0064
AMICAS WEB/INTRANET IMAGE SERVER
K
96
5161
SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)
K
96
4250
LINX NETWORKING SYSTEM
K
96
3861
LASERSHARE PRINT SPOOLER AND/OR SOFTWARE
K
96
3628
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE
K
96
3592
IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000
K
96
3594
IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)
K
96
2225
VIEWSEND MEDICAL MODEL 1200
K
96
1023
AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR)
K
96
2699
RADWORKS MEDICAL IMAGING SOFTWARE
K
96
1689
INFINET
K
96
1753
SHARED VISION(PART NUMBER SV 0015)
K
96
0911
NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE
K
96
0382
KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER
K
95
4567
RTI MEDICAL
K
96
0809
PHILIPS SITE VIEW WORKSTATION
K
95
4691
ACCESS RADIOLOGY TELERADIOLOGY IMAGE ACQUISITION & DISTRIBUTION SYSTEM
K
95
4172
X-RAY VISIONS
K
95
5708
COMPUMED DICON CLIENT
K
95
4071
IDXVIEW
K
95
4479
DICOMVIEW
K
95
5000
REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE
K
95
0513
ARCHIVEMANAGER
K
95
4008
REDI-VU SYSTEMS (SEND & RECEIVE)
K
95
3552
SIENET SPI SPOOLER
K
95
3371
LUMISYS DICOM TOOKLIT
K
95
3514
COURIER II
K
95
3398
UNISCAN
K
95
3080
DIGITAL IMAGING SYSTEM INTERFACE
K
95
3163
QUICK READ 2000 (QR2000)
K
95
2914
STAR TECHNOLOGIES, INC. FILM IMAGE SCAN SYSTEM
K
95
2533
SIENET DICOM GATEWAY
K
95
1175
MEDICAL IMAGING INFORMATION AND CAPTURE SYSTEM (MIICS)
K
95
0413
MEDIPACS
K
95
2484
MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A
K
94
3994
PACS EQUIPMENT
K
95
0431
LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM
K
95
0699
PREVIEW TELEIMAGING SYSTEM
K
95
0343
HYPERPACS PACS AND TELERAFIOLOGY SYSTEM
K
94
4322
AT&T IMAGE SOLUTIONS PICASSO STILL-IMAGE PHONE SYSTEM
K
92
5964
IMAGE TRANSPORT SERIES III
K
94
0859
PACSPRO I
K
94
4771
INTRASCAN II
K
94
4130
RIT 531 TELERADIOLOGY/ PAC SYSTEM
K
94
1224
LENZAR REMOTE ACQUISITION SYSTEM
K
94
2861
MEDVISION ENVIROMENT/MEDVISION 2.0
K
94
3383
IMAGING WORKBENCH
K
94
3158
AD/V IMAGEPLEX(TM)
K
94
2917
ULTRAPRO WORKSTATION
K
94
0423
NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE
K
94
1203
MEDICAL IMAGING WORKSTATION II (MIW II)
K
94
1086
PACSPRO II
K
94
0408
REMOTE CONSOLE
K
93
6153
3M 1156 MULTI-INPUT SYSTEM
K
93
6116
KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS
K
93
5103
VISIONLINK ACR-NEMA CONVERSION UTILITIES
K
93
4386
IMPAX 5000
K
93
0500
MAXIVIEW DIAGNOSTIC WORKSTATION
K
92
6315
PRACTICE PARTNER
K
93
1186
PHOTOPHONE MULTIVIEW
K
93
1795
TELERAD STAT
K
93
3409
IMPAX 1000
K
93
3103
DIGITAL IMAGE COMMUNICATIONS SYSTEM
K
93
3098
MEDICAL IMAGE MANAGEMENT SYSTEM/X-RAY TERMINAL
K
92
5864
COURIER PC
K
93
1292
MULTIVIEW FOR WINDOWS
K
93
1551
KODAK EKTASCAN IMAGELINK SYSTEM (KEIS)
K
92
6098
DIGIRAY
K
93
1060
STATVIEW
K
92
5050
PC TELERADIOLOGY(TM)
K
93
0350
RADMAN IMAGE MANAGMENT SYSTEM
K
93
0997
DOMINATOR RADIOLOGY SYSTEM
K
92
1185
TELEMEDIC TELERADIOLOGY SYSTEM
K
92
5994
RSTAR IMAGE MANAGMENT SYTEM (RSTAR-IMS)
K
92
5929
RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS)
K
92
4178
MEDVISION(TM) IMAGING SOFTWARE
K
92
5284
IMAGESSSHARE 910
K
92
2164
RAYTEL DIGITAL IMAGING SYSTEMS
K
92
5097
VORTECH'S AUTOROUTER (AUTOMATIC IMAGE ROUTING)
K
92
4229
VG-A MIG
K
92
3582
SIENET CAMERA SERVER
K
92
1877
AD/V SPOOLER
K
92
1527
STATVIEW
K
92
0268
3M DIGITAL DISK INTERFACE UNIT
K
92
1278
M-2000 DIAGNOSTIC AND TELERADIOLOGY WORKSTATION
K
92
0310
SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE
K
91
4444
XPR PRINTER REDUNDANCY
K
91
4191
XLP NETWORK PRINTING
K
91
1773
PHILIPS TELESCAN
K
91
1405
KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T
K
90
5199
PACSNET RESEARCH TOOLKIT
K
90
0935
DU PONT LINX LASER IMAGER W/THE LINX NETWORKING
K
89
6095
IMAGES-ON-CALL TELERADIOLOGY SYSTEM
K
90
0227
MVP (MULTI-VENDOR PROTOCOL CONVERTOR)
K
89
5209
FILMFAX
K
89
1192
MEDI-TRACE THERMAL VIDEO FILM PAPER
K
88
4434
VORTECH'S MEDICAL IMAGING GATEWAY
K
88
2754
REPORT AND IMAGE MANAGEMENT SYSTEM
K
87
3121
GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS)
K
87
1984
KODAK EKTASCAN IMAGE TRANS. T1/R1 & P1 SOFTWARE
K
86
2158
AVP TELEIMAGING SYSTEM
K
86
2744
TELERADIOGRAPHY SYSTEM
K
86
2715
COMMVIEW SYSTEM
K
85
0417
INTERFACE MODULES IM 1000 IMAGE COMMUNI-NETWORK
LNH
System, Nuclear Magnetic Resonance Imaging
LNI
System, Nuclear Magnetic Resonance Spectroscopic
LQA
Media, Reusable Image
MOS
Coil, Magnetic Resonance, Specialty
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
MUA
Bone Sonometer
MUE
Full Field Digital, System, X-Ray, Mammographic
MUI
Media, Coupling, Ultrasound
MWP
Cabinet, X-Ray System
MYN
Analyzer, Medical Image
NCS
System, Imaging, Holography, Acoustic
NWE
Colon Computed Tomography System, Computer Aided Detection
OAS
X-Ray, Tomography, Computed, Dental
OEB
Lung Computed Tomography System, Computer-Aided Detection
OII
Arthrogram Tray
OIJ
Biopsy Needle Guide Kit
OIK
Radiology Dental Tray
OIL
Discography Kit
OIM
Mri Disposable Kit
OIO
Radiographic Contrast Tray
OIP
Radiology-Diagnostic Kit
OMJ
Chest X-Ray Computer Aided Detection
OQQ
Diagnostic Ultrasonic Transducer, Robotic
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
OWB
Interventional Fluoroscopic X-Ray System
OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
PGY
Display, Diagnostic Radiology
POK
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
QAS
Radiological Computer-Assisted Triage And Notification Software
QFM
Radiological Computer-Assisted Prioritization Software For Lesions
QHA
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
QHX
Fluoroscopic X-Ray Image Intensifier
QHY
Solid State Fluoroscopic X-Ray Imager
QIH
Automated Radiological Image Processing Software
QKB
Radiological Image Processing Software For Radiation Therapy
RCC
C-Arm Fluoroscopic X-Ray System
QTZ
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
QXL
Cabinet, Emission Computed Tomography System
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous Devices
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
RA
/
subpart-b—diagnostic-devices
/
LMD
/
K925864
View Source
COURIER PC
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K925864
510(k) Type
Traditional
Applicant
SHORELINE BUSINESS CONSULTING
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/20/1993
Days to Decision
305 days
Submission Type
Summary