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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
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Orthopedic
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Pathology
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Physical Medicine
Review Panel
Radiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
EAG
Cephalometer
2
Product Code
EAH
Cone, Radiographic, Lead-Lined
1
Product Code
EAP
Unit, X-Ray, Intraoral
2
Product Code
EHB
Collimator, X-Ray
1
Product Code
EHD
Unit, X-Ray, Extraoral With Timer
2
Product Code
MUH
System, X-Ray, Extraoral Source, Digital
2
Product Code
EAM
Screen, Intensifying, Radiographic
1
Product Code
EGT
Controller, Temperature, Radiographic
2
Product Code
EGW
Dryer, Film, Radiographic
2
Product Code
EGY
Processor, Radiographic-Film, Automatic, Dental
2
Product Code
HBK
Chair, Pneumoencephalographic
2
Product Code
ITX
Transducer, Ultrasonic, Diagnostic
2
Product Code
ITY
Assembly, Tube Housing, X-Ray, Diagnostic
1
Product Code
IWN
Cassette, Measurement, Ardran-Crooks
1
Product Code
IWY
Holder, Head, Radiographic
1
Product Code
IWZ
Film, Radiographic
1
Product Code
IXA
Cassette, Radiographic Film
2
Product Code
IXC
Illuminator, Radiographic-Film
1
Product Code
IXD
Source, Calibration, Sealed, Nuclear
1
Product Code
IXF
Test-Pattern, Radiographic
1
Product Code
IXG
Phantom, Anthropomorphic, Radiographic
1
Product Code
IXH
Camera, Focal Spot, Radiographic
1
Product Code
IXJ
Grid, Radiographic
1
Product Code
IXK
System, Imaging, X-Ray, Electrostatic
2
Product Code
IXL
Device, Spot-Film
2
Product Code
IXO
Synchronizer, Ecg / Respirator, Radiographic
1
Product Code
IXQ
Table, Radiographic, Stationary Top
2
Product Code
IXR
Table, Radiographic, Tilting
2
Product Code
IXW
Processor, Radiographic-Film, Automatic
2
Product Code
IXX
Processor, Cine Film
2
Product Code
IXY
Holder, Radiographic Cassette, Wall-Mounted
1
Product Code
IYB
Tube Mount, X-Ray, Diagnostic
1
Product Code
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
2
Product Code
IYO
System, Imaging, Pulsed Echo, Ultrasonic
2
Product Code
IYP
Phantom, Anthropomorphic, Nuclear
1
Product Code
IYQ
Phantom, Flood Source, Nuclear
1
Product Code
IYT
System, Rebreathing, Radionuclide
2
Product Code
IYW
Scanner, Rectilinear, Nuclear
1
Product Code
IYX
Camera, Scintillation (Gamma)
1
Product Code
IYY
Synchronizer, Electrocardiograph, Nuclear
1
Product Code
IYZ
Bed, Scanning, Nuclear
1
Product Code
IZC
Camera, Positron
1
Product Code
IZD
Probe, Uptake, Nuclear
1
Product Code
IZF
System, X-Ray, Tomographic
2
Product Code
IZG
System, X-Ray, Photofluorographic
2
Product Code
IZH
System, X-Ray, Mammographic
2
Product Code
IZI
System, X-Ray, Angiographic
2
Product Code
IZJ
Camera, X-Ray, Fluorographic, Cine Or Spot
2
Product Code
IZL
System, X-Ray, Mobile
2
Product Code
IZO
Generator, High-Voltage, X-Ray, Diagnostic
1
Product Code
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
K
14
1454
SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD
2
Cleared 510(K)
K
14
1346
SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD
2
Cleared 510(K)
K
11
1566
DRYVIEW CHROMA IMAGING SYSTEM
2
Cleared 510(K)
K
09
2280
CYPHER DICOM PRINT SOLUTION
2
Cleared 510(K)
K
09
0469
CARESTREAM DRYVIEW 5850 LASER IMAGER
2
Cleared 510(K)
K
08
3522
SONY UP-DF750 DIGITAL FILM IMAGER
2
Cleared 510(K)
K
08
1637
LASER IMAGER DRYPRO MODEL 873
2
Cleared 510(K)
K
07
2680
DRYSTAR AXYS, MODEL EYZ4E
2
Cleared 510(K)
K
06
1999
DRY LASER IMAGER, DRYPRO MODEL 832
2
Cleared 510(K)
K
06
1302
DIGITAL PRINTER P6000D SERIES, MODEL P6000DU
2
Cleared 510(K)
K
06
0440
CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER
2
Cleared 510(K)
K
05
2251
DRYSTAR MODEL 5500
2
Cleared 510(K)
K
04
2133
DRY LASER IMAGER, MODEL DRYPRO MODEL 793
2
Cleared 510(K)
K
04
2232
NP-2600 SERIES HARDCOPY PRINTERS
2
Cleared 510(K)
K
04
2159
KODAK COLOR MEDICAL IMAGER 1000
2
Cleared 510(K)
K
04
2158
KODAK MEDICAL IMAGER 300
2
Cleared 510(K)
K
03
3821
KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY
2
Cleared 510(K)
K
03
3377
FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L
2
Cleared 510(K)
K
03
2681
KONICA LASER IMAGER, MODEL DRYPRO MODEL 771
2
Cleared 510(K)
K
03
2635
DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300
2
Cleared 510(K)
K
03
0690
CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS
2
Cleared 510(K)
K
02
4188
UP-DF500 FILMSTATION DIGITAL FILM IMAGER
2
Cleared 510(K)
K
02
3287
DRYSTAR 5500
2
Cleared 510(K)
K
02
2658
LR DICOM CONTROLLER
2
Cleared 510(K)
K
02
1054
CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER
2
Cleared 510(K)
K
01
3052
KONICA LASER IMAGER, DRYPRO MODEL 751/752
2
Cleared 510(K)
K
01
2941
DRYSTAR, MODEL 4500M
2
Cleared 510(K)
K
01
2010
MODIFICATION TO LR 5200 FILM RECORDER
2
Cleared 510(K)
K
01
1949
ELK LASER IMAGER, MODEL EL-DRY 4000
2
Cleared 510(K)
K
01
1617
LIFEJET PRINTER 400
2
Cleared 510(K)
K
01
0275
DRYSTAR 4500 PRINTER, MODEL 4500
2
Cleared 510(K)
K
00
3481
CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660
2
Cleared 510(K)
K
00
2146
KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY
2
Cleared 510(K)
K
99
2586
KONICA LASER IMAGER, DRYPRO MODEL 722
2
Cleared 510(K)
K
99
1282
COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES
2
Cleared 510(K)
K
98
3905
KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600
2
Cleared 510(K)
K
97
2822
IMATION SE-204 LASER IMAGER
2
Cleared 510(K)
K
97
2660
RAVEN DRY PRINTER
2
Cleared 510(K)
K
97
3422
LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT])
2
Cleared 510(K)
K
97
3028
HELIOS LASER IMAGER 1417
2
Cleared 510(K)
K
97
2847
KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D)
2
Cleared 510(K)
K
97
1760
COLORPOINT OR PROFESSIONAL COLORPOINT
2
Cleared 510(K)
K
97
2163
IMATION SE-196 LASER IMAGER
2
Cleared 510(K)
K
96
4414
LR 5200 LASER FILM RECORDER
2
Cleared 510(K)
K
96
2364
CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD)
2
Cleared 510(K)
K
96
2967
FUJI MEDICAL DRY IMAGER FM-DP 2636
2
Cleared 510(K)
K
96
2051
ASPECT OPTICAM
2
Cleared 510(K)
K
95
3165
ULTRA COMPACT VIDEO IMAGER
2
Cleared 510(K)
K
95
5394
SIENET TELERADIOLOGY PRODUCT LINE
2
Cleared 510(K)
K
95
4149
ASPECT DIGITAL FORMATTER
2
Cleared 510(K)
K
95
3475
CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING
2
Cleared 510(K)
K
95
3477
MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING
2
Cleared 510(K)
K
95
4198
VOXCAM
2
Cleared 510(K)
K
95
1948
KODAK XLS 8600 (PS)
2
Cleared 510(K)
K
95
1807
KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER
2
Cleared 510(K)
K
95
0359
KONICA LASER IMAGER LI-21
2
Cleared 510(K)
K
95
0721
FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L
2
Cleared 510(K)
K
95
0423
MINI IMAGER
2
Cleared 510(K)
K
95
0610
FIKO FO;, TJER,A; O,AGER FTO-1000
2
Cleared 510(K)
K
95
0288
AUTOLASER MULTI FORMAT CAMERA
2
Cleared 510(K)
K
94
5475
FUJI MEDICAL LASER IMAGER FL-IM D
2
Cleared 510(K)
K
93
6152
3M 1152 LASER IMAGER
2
Cleared 510(K)
K
93
6142
3M 1154 LASER IMAGER
2
Cleared 510(K)
K
94
0332
MODEL FORTY ULTRA COMPACT VIDEO IMAGER
2
Cleared 510(K)
K
93
0755
ULTRA COMPACT VIDEO IMAGER
2
Cleared 510(K)
K
92
5650
IMAGEVIEW 5000
2
Cleared 510(K)
K
92
5265
IMAGEVIEW 46000
2
Cleared 510(K)
K
92
5220
PMI100 VIDEO IMAGER
2
Cleared 510(K)
K
92
3481
PHILIPS LASER DISK ARCHIVE
2
Cleared 510(K)
K
92
5289
MATRIX CR 2050, PMI 3000
2
Cleared 510(K)
K
92
1215
LASERSTAR IMAGER
2
Cleared 510(K)
K
92
3536
NUCLEAR MEDICINE LASER IMAGER
2
Cleared 510(K)
K
92
1906
HARRIS MODEL 2000
2
Cleared 510(K)
K
92
1381
MEDGRAPHIX INTL VR 1000 SERIES
2
Cleared 510(K)
K
92
3222
3M COLOR LASER IMAGER, MODEL 979
2
Cleared 510(K)
K
92
3075
3M LASER IMAGER MODEL 969
2
Cleared 510(K)
K
92
2411
KODAK EKTASCAN, XLT7720, XLT7700, PCD 2000
2
Cleared 510(K)
K
92
1992
MP3000 SERIES III VIDEO IMAGER
2
Cleared 510(K)
K
92
1743
KODAK EKTASCAN 2180 LASER PRINTER
2
Cleared 510(K)
K
92
0769
KONICA LI 10 AND 10A LASER IMAGER
2
Cleared 510(K)
K
91
4834
VORTECH 3M NETWORK PRINTING
2
Cleared 510(K)
K
91
4582
KODAK EKTASCAN 1120 LASER PRINTER
2
Cleared 510(K)
K
91
2799
EAGLE SYSTEM
2
Cleared 510(K)
K
91
2073
POLAROID HELIOS LASER IMAGER
2
Cleared 510(K)
K
91
1437
KODAK EKTASCAN CABLE EXTENSION
2
Cleared 510(K)
K
91
0092
3M LASER IMAGER XL
2
Cleared 510(K)
K
90
2347
COMPACT LASER IMAGER, MODEL CLI-100
2
Cleared 510(K)
K
90
5566
KODAK EKTASCAN MULTI-FORMAT IMAGER VARIOUS MODELS
2
Cleared 510(K)
K
90
4897
MODEL 400 ULTRA COMPACT VIDEO IMAGER
2
Cleared 510(K)
K
90
4363
MULTI FORMAT VIDEO IMAGER 600 PLUS
2
Cleared 510(K)
K
90
3238
AFGA VIDEO IMAGER, VARIOUS MODELS
2
Cleared 510(K)
K
90
0896
6000 PLUS MULTI-FORMAT VIDEO IMAGER
2
Cleared 510(K)
K
90
0901
MP4000 SERIES II COMPACT VIDEO IMAGER
2
Cleared 510(K)
K
90
0900
MP3000 SERIES II COMPACT VIDEO IMAGER
2
Cleared 510(K)
K
90
0899
MP3000 COMPACT VIDEO IMAGER
2
Cleared 510(K)
K
90
0898
9000 ECONOMICAL 14 X 17 VIDEO IMAGER
2
Cleared 510(K)
K
90
0897
5000/5000C MULTI-FORMAT CAMERAS FOR NUCLEAR MEDI.
2
Cleared 510(K)
K
90
0885
FUJI MEDICAL LASER IMAGER
2
Cleared 510(K)
K
89
6683
COMPACT VIDEO IMAGER MP4000 SERIES III
2
Cleared 510(K)
K
89
5668
DIGICAM LHP (VIDEO INTERFACE OPTION)
2
Cleared 510(K)
K
89
1924
SCOPIX LASER IMAGER
2
Cleared 510(K)
K
88
3324
DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE)
2
Cleared 510(K)
K
89
0097
KODAK EKTASCAN LASER PRINTER DIGITAL, MODEL 1000
2
Cleared 510(K)
K
88
5127
SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM
2
Cleared 510(K)
K
88
2096
SCOPIX VIDEO IMAGER
2
Cleared 510(K)
K
88
2483
FTI 200 MEDICAL THERMAL IMAGER
2
Cleared 510(K)
K
87
1957
SPACEMISER 8-10 FILM RECORDER
2
Cleared 510(K)
K
87
1959
FRANTZ IMAGING COMPACT CAMERA
2
Cleared 510(K)
K
87
1958
SPACEMISER 8-17 FILM RECORDER
2
Cleared 510(K)
K
87
1778
DIGISPOT IMAGER
2
Cleared 510(K)
K
86
3629
KODAK EKTASCAN LASER PRINTER, MODEL 100
2
Cleared 510(K)
K
86
3856
S-RAY CAMERA
2
Cleared 510(K)
K
86
2416
FTI 100 MEDICAL THERMAL IMAGER
2
Cleared 510(K)
K
86
0776
MATRIX LR, LR 22A & LR/LASER RECORDER
2
Cleared 510(K)
K
86
0761
MULTI-IMAGE CAMERA, SERIES 2100, MODEL #2100-06
2
Cleared 510(K)
K
86
0691
KODAK EKTASCAN VIDEO CAMERA & COMPACT VIDEO CAMERA
2
Cleared 510(K)
K
85
5043
3M DRY SILVER IMAGER
2
Cleared 510(K)
K
85
0184
MEDICAL MULTI-IMAGE CAMERA-676
2
Cleared 510(K)
K
84
3502
3M LASER IMAGER
2
Cleared 510(K)
K
84
3582
MULTI-FORMAT FILM CAMERA
2
Cleared 510(K)
K
84
0385
VIDEO PRINT
2
Cleared 510(K)
LMD
System, Digital Image Communications, Radiological
1
Product Code
LNH
System, Nuclear Magnetic Resonance Imaging
2
Product Code
LNI
System, Nuclear Magnetic Resonance Spectroscopic
2
Product Code
LQA
Media, Reusable Image
1
Product Code
MOS
Coil, Magnetic Resonance, Specialty
2
Product Code
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
2
Product Code
MUA
Bone Sonometer
2
Product Code
MUE
Full Field Digital, System, X-Ray, Mammographic
2
Product Code
MUI
Media, Coupling, Ultrasound
2
Product Code
MWP
Cabinet, X-Ray System
2
Product Code
MYN
Analyzer, Medical Image
2
Product Code
NCS
System, Imaging, Holography, Acoustic
2
Product Code
NWE
Colon Computed Tomography System, Computer Aided Detection
2
Product Code
OAS
X-Ray, Tomography, Computed, Dental
2
Product Code
OEB
Lung Computed Tomography System, Computer-Aided Detection
2
Product Code
OII
Arthrogram Tray
2
Product Code
OIJ
Biopsy Needle Guide Kit
2
Product Code
OIK
Radiology Dental Tray
2
Product Code
OIL
Discography Kit
2
Product Code
OIM
Mri Disposable Kit
2
Product Code
OIO
Radiographic Contrast Tray
2
Product Code
OIP
Radiology-Diagnostic Kit
2
Product Code
OMJ
Chest X-Ray Computer Aided Detection
2
Product Code
OQQ
Diagnostic Ultrasonic Transducer, Robotic
2
Product Code
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
2
Product Code
OWB
Interventional Fluoroscopic X-Ray System
2
Product Code
OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
2
Product Code
PGY
Display, Diagnostic Radiology
2
Product Code
POK
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
2
Product Code
QAS
Radiological Computer-Assisted Triage And Notification Software
2
Product Code
QFM
Radiological Computer-Assisted Prioritization Software For Lesions
2
Product Code
QHA
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
2
Product Code
QHX
Fluoroscopic X-Ray Image Intensifier
1
Product Code
QHY
Solid State Fluoroscopic X-Ray Imager
2
Product Code
QIH
Automated Radiological Image Processing Software
2
Product Code
QKB
Radiological Image Processing Software For Radiation Therapy
2
Product Code
RCC
C-Arm Fluoroscopic X-Ray System
2
Product Code
QTZ
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
2
Product Code
QXL
Cabinet, Emission Computed Tomography System
2
Product Code
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 6 December 2024 at 11:05 pm
RA
/
subpart-b—diagnostic-devices
/
LMC
/
K962967
View Source
FUJI MEDICAL DRY IMAGER FM-DP 2636
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K962967
510(k) Type
Traditional
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/28/1996
Days to Decision
90 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
K
14
1454
SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD
K
14
1346
SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD
K
11
1566
DRYVIEW CHROMA IMAGING SYSTEM
K
09
2280
CYPHER DICOM PRINT SOLUTION
K
09
0469
CARESTREAM DRYVIEW 5850 LASER IMAGER
K
08
3522
SONY UP-DF750 DIGITAL FILM IMAGER
K
08
1637
LASER IMAGER DRYPRO MODEL 873
K
07
2680
DRYSTAR AXYS, MODEL EYZ4E
K
06
1999
DRY LASER IMAGER, DRYPRO MODEL 832
K
06
1302
DIGITAL PRINTER P6000D SERIES, MODEL P6000DU
K
06
0440
CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER
K
05
2251
DRYSTAR MODEL 5500
K
04
2133
DRY LASER IMAGER, MODEL DRYPRO MODEL 793
K
04
2232
NP-2600 SERIES HARDCOPY PRINTERS
K
04
2159
KODAK COLOR MEDICAL IMAGER 1000
K
04
2158
KODAK MEDICAL IMAGER 300
K
03
3821
KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY
K
03
3377
FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L
K
03
2681
KONICA LASER IMAGER, MODEL DRYPRO MODEL 771
K
03
2635
DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300
K
03
0690
CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS
K
02
4188
UP-DF500 FILMSTATION DIGITAL FILM IMAGER
K
02
3287
DRYSTAR 5500
K
02
2658
LR DICOM CONTROLLER
K
02
1054
CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER
K
01
3052
KONICA LASER IMAGER, DRYPRO MODEL 751/752
K
01
2941
DRYSTAR, MODEL 4500M
K
01
2010
MODIFICATION TO LR 5200 FILM RECORDER
K
01
1949
ELK LASER IMAGER, MODEL EL-DRY 4000
K
01
1617
LIFEJET PRINTER 400
K
01
0275
DRYSTAR 4500 PRINTER, MODEL 4500
K
00
3481
CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660
K
00
2146
KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY
K
99
2586
KONICA LASER IMAGER, DRYPRO MODEL 722
K
99
1282
COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES
K
98
3905
KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600
K
97
2822
IMATION SE-204 LASER IMAGER
K
97
2660
RAVEN DRY PRINTER
K
97
3422
LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT])
K
97
3028
HELIOS LASER IMAGER 1417
K
97
2847
KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D)
K
97
1760
COLORPOINT OR PROFESSIONAL COLORPOINT
K
97
2163
IMATION SE-196 LASER IMAGER
K
96
4414
LR 5200 LASER FILM RECORDER
K
96
2364
CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD)
K
96
2967
FUJI MEDICAL DRY IMAGER FM-DP 2636
K
96
2051
ASPECT OPTICAM
K
95
3165
ULTRA COMPACT VIDEO IMAGER
K
95
5394
SIENET TELERADIOLOGY PRODUCT LINE
K
95
4149
ASPECT DIGITAL FORMATTER
K
95
3475
CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING
K
95
3477
MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING
K
95
4198
VOXCAM
K
95
1948
KODAK XLS 8600 (PS)
K
95
1807
KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER
K
95
0359
KONICA LASER IMAGER LI-21
K
95
0721
FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L
K
95
0423
MINI IMAGER
K
95
0610
FIKO FO;, TJER,A; O,AGER FTO-1000
K
95
0288
AUTOLASER MULTI FORMAT CAMERA
K
94
5475
FUJI MEDICAL LASER IMAGER FL-IM D
K
93
6152
3M 1152 LASER IMAGER
K
93
6142
3M 1154 LASER IMAGER
K
94
0332
MODEL FORTY ULTRA COMPACT VIDEO IMAGER
K
93
0755
ULTRA COMPACT VIDEO IMAGER
K
92
5650
IMAGEVIEW 5000
K
92
5265
IMAGEVIEW 46000
K
92
5220
PMI100 VIDEO IMAGER
K
92
3481
PHILIPS LASER DISK ARCHIVE
K
92
5289
MATRIX CR 2050, PMI 3000
K
92
1215
LASERSTAR IMAGER
K
92
3536
NUCLEAR MEDICINE LASER IMAGER
K
92
1906
HARRIS MODEL 2000
K
92
1381
MEDGRAPHIX INTL VR 1000 SERIES
K
92
3222
3M COLOR LASER IMAGER, MODEL 979
K
92
3075
3M LASER IMAGER MODEL 969
K
92
2411
KODAK EKTASCAN, XLT7720, XLT7700, PCD 2000
K
92
1992
MP3000 SERIES III VIDEO IMAGER
K
92
1743
KODAK EKTASCAN 2180 LASER PRINTER
K
92
0769
KONICA LI 10 AND 10A LASER IMAGER
K
91
4834
VORTECH 3M NETWORK PRINTING
K
91
4582
KODAK EKTASCAN 1120 LASER PRINTER
K
91
2799
EAGLE SYSTEM
K
91
2073
POLAROID HELIOS LASER IMAGER
K
91
1437
KODAK EKTASCAN CABLE EXTENSION
K
91
0092
3M LASER IMAGER XL
K
90
2347
COMPACT LASER IMAGER, MODEL CLI-100
K
90
5566
KODAK EKTASCAN MULTI-FORMAT IMAGER VARIOUS MODELS
K
90
4897
MODEL 400 ULTRA COMPACT VIDEO IMAGER
K
90
4363
MULTI FORMAT VIDEO IMAGER 600 PLUS
K
90
3238
AFGA VIDEO IMAGER, VARIOUS MODELS
K
90
0896
6000 PLUS MULTI-FORMAT VIDEO IMAGER
K
90
0901
MP4000 SERIES II COMPACT VIDEO IMAGER
K
90
0900
MP3000 SERIES II COMPACT VIDEO IMAGER
K
90
0899
MP3000 COMPACT VIDEO IMAGER
K
90
0898
9000 ECONOMICAL 14 X 17 VIDEO IMAGER
K
90
0897
5000/5000C MULTI-FORMAT CAMERAS FOR NUCLEAR MEDI.
K
90
0885
FUJI MEDICAL LASER IMAGER
K
89
6683
COMPACT VIDEO IMAGER MP4000 SERIES III
K
89
5668
DIGICAM LHP (VIDEO INTERFACE OPTION)
K
89
1924
SCOPIX LASER IMAGER
K
88
3324
DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE)
K
89
0097
KODAK EKTASCAN LASER PRINTER DIGITAL, MODEL 1000
K
88
5127
SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM
K
88
2096
SCOPIX VIDEO IMAGER
K
88
2483
FTI 200 MEDICAL THERMAL IMAGER
K
87
1957
SPACEMISER 8-10 FILM RECORDER
K
87
1959
FRANTZ IMAGING COMPACT CAMERA
K
87
1958
SPACEMISER 8-17 FILM RECORDER
K
87
1778
DIGISPOT IMAGER
K
86
3629
KODAK EKTASCAN LASER PRINTER, MODEL 100
K
86
3856
S-RAY CAMERA
K
86
2416
FTI 100 MEDICAL THERMAL IMAGER
K
86
0776
MATRIX LR, LR 22A & LR/LASER RECORDER
K
86
0761
MULTI-IMAGE CAMERA, SERIES 2100, MODEL #2100-06
K
86
0691
KODAK EKTASCAN VIDEO CAMERA & COMPACT VIDEO CAMERA
K
85
5043
3M DRY SILVER IMAGER
K
85
0184
MEDICAL MULTI-IMAGE CAMERA-676
K
84
3502
3M LASER IMAGER
K
84
3582
MULTI-FORMAT FILM CAMERA
K
84
0385
VIDEO PRINT
LMD
System, Digital Image Communications, Radiological
LNH
System, Nuclear Magnetic Resonance Imaging
LNI
System, Nuclear Magnetic Resonance Spectroscopic
LQA
Media, Reusable Image
MOS
Coil, Magnetic Resonance, Specialty
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
MUA
Bone Sonometer
MUE
Full Field Digital, System, X-Ray, Mammographic
MUI
Media, Coupling, Ultrasound
MWP
Cabinet, X-Ray System
MYN
Analyzer, Medical Image
NCS
System, Imaging, Holography, Acoustic
NWE
Colon Computed Tomography System, Computer Aided Detection
OAS
X-Ray, Tomography, Computed, Dental
OEB
Lung Computed Tomography System, Computer-Aided Detection
OII
Arthrogram Tray
OIJ
Biopsy Needle Guide Kit
OIK
Radiology Dental Tray
OIL
Discography Kit
OIM
Mri Disposable Kit
OIO
Radiographic Contrast Tray
OIP
Radiology-Diagnostic Kit
OMJ
Chest X-Ray Computer Aided Detection
OQQ
Diagnostic Ultrasonic Transducer, Robotic
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
OWB
Interventional Fluoroscopic X-Ray System
OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
PGY
Display, Diagnostic Radiology
POK
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
QAS
Radiological Computer-Assisted Triage And Notification Software
QFM
Radiological Computer-Assisted Prioritization Software For Lesions
QHA
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
QHX
Fluoroscopic X-Ray Image Intensifier
QHY
Solid State Fluoroscopic X-Ray Imager
QIH
Automated Radiological Image Processing Software
QKB
Radiological Image Processing Software For Radiation Therapy
RCC
C-Arm Fluoroscopic X-Ray System
QTZ
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
QXL
Cabinet, Emission Computed Tomography System
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous Devices
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
RA
/
subpart-b—diagnostic-devices
/
LMC
/
K962967
View Source
FUJI MEDICAL DRY IMAGER FM-DP 2636
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K962967
510(k) Type
Traditional
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/28/1996
Days to Decision
90 days
Submission Type
Summary