FDA Browser
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
K
11
1167
XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT
2
Cleared 510(K)
K
09
3503
INTRAX FILM PROCESSOR
2
Cleared 510(K)
K
09
1628
OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX
2
Cleared 510(K)
K
02
4342
RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000
2
Cleared 510(K)
K
02
3801
FILM PROCESSOR, MODEL LIFE RAY PRO 1000
2
Cleared 510(K)
K
02
3825
FILM PROCESSOR, MODEL LIFE RAY PRO 2500
2
Cleared 510(K)
K
02
3613
AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
2
Cleared 510(K)
K
02
2154
LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D
2
Cleared 510(K)
K
00
2640
FREEDOM AUTOMATIC FILM PROCESSOR
2
Cleared 510(K)
K
00
2404
MICRO-MAX, MODEL 319
2
Cleared 510(K)
K
00
1321
ALL-PRO 2010
2
Cleared 510(K)
K
99
2818
OPTIMAX/ COMPACT 2
2
Cleared 510(K)
K
99
0969
KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
99
1435
AII-PRO 100 PLUS AND ALL-PRO 200
2
Cleared 510(K)
K
98
1280
CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS
2
Cleared 510(K)
K
97
3125
MAMMOLOADER BY C.M.A. SRL
2
Cleared 510(K)
K
97
0059
KODAK MINILOADER(2000)
2
Cleared 510(K)
K
96
2750
3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR
2
Cleared 510(K)
K
95
5706
JPI AUTOMATIC X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
95
1373
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ
2
Cleared 510(K)
K
95
4484
KODAK AUTOMIXER II PLUS
2
Cleared 510(K)
K
95
4345
DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
95
1397
KODAK X-OMAT 5000 RA PROCESSOR
2
Cleared 510(K)
K
95
1396
KODAK X-OMAT 3000 RA PROCESSOR
2
Cleared 510(K)
K
94
4046
FUJI COMPUTED RADIOGRAPHY SYSTEMS
2
Cleared 510(K)
K
95
0043
JPI AUTOMATIC X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
94
0112
X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
95
0358
KONICA SRX-201 AUTOMATIC X-RA FILM PROCESSOR
2
Cleared 510(K)
K
94
0540
VELO ACE
2
Cleared 510(K)
K
94
0558
3M XP-2000 X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
93
4350
KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS
2
Cleared 510(K)
K
93
5957
FUJI MEDICAL FILM PROCESSOR FPM2800
2
Cleared 510(K)
K
93
1316
KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
93
1315
KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
93
1317
KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
93
3001
KODAK XML 300 DARKROOM FILM FEEDER
2
Cleared 510(K)
K
93
1313
KONICA QX-130APLUS AUTOMATIC X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
93
1314
KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
93
1312
KONICA SRX-101 AUTOMATIC X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
93
1882
MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
93
1883
AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033
2
Cleared 510(K)
K
93
3408
FUJI DAYLIGHT CASSETTE MULTI-LOADER
2
Cleared 510(K)
K
92
5885
AFP 17 X 4 AUTOMATIC FILM PROCESSOR
2
Cleared 510(K)
K
92
3554
KODAK EKTASCAN
2
Cleared 510(K)
K
92
5569
AX-700LE AUTOMATIC X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
92
4552
DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II)
2
Cleared 510(K)
K
92
4430
AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027
2
Cleared 510(K)
K
92
3552
KODAK X-OMAT FS-1A PROCESSOR
2
Cleared 510(K)
K
92
1269
KODAK X-OMAT MODEL 180 LP PROCESSOR
2
Cleared 510(K)
K
92
0715
KODAK X-OMAT FIXER MANAGER
2
Cleared 510(K)
K
91
4143
KODAK X-OMAT 480 RA PROCESSOR
2
Cleared 510(K)
K
91
3354
KODAK EKTASCAN STORAGE PHOSPHOR READER MODEL 1A
2
Cleared 510(K)
K
91
2225
3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT
2
Cleared 510(K)
K
91
1291
ALL-PRO 100
2
Cleared 510(K)
K
91
1711
KODAK AUTOMATIC FILM FEEDER, MODEL RA
2
Cleared 510(K)
K
91
1713
KODAK 100-J & 100-K CHEMICAL MIXERS
2
Cleared 510(K)
K
91
1714
KODAK M35-MX-0MAT PROCESSOR
2
Cleared 510(K)
K
90
5607
KODAK X-OMAT MULTILOADER 300
2
Cleared 510(K)
K
90
4238
KODAK X-MAT 270 RA PROCESSOR
2
Cleared 510(K)
K
90
2732
KODAK X-OMAT 460 RA PROCESSOR
2
Cleared 510(K)
K
90
1772
KODAK M35A-M X-OMAT PROCESSOR
2
Cleared 510(K)
K
89
0486
MXR-14 FILM PROCESSOR
2
Cleared 510(K)
K
88
5207
KODAK MULTILOADER 700
2
Cleared 510(K)
K
88
2320
KODAK EKTASCAN LASER PRINTER ADAPTER, MODEL M6/M8
2
Cleared 510(K)
K
88
1248
KODAK AUTOMATIC FILM FEEDER, MODEL 11
2
Cleared 510(K)
K
88
0563
3M XP515 X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
88
0565
3M TRIMATIC M MODULAR SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
88
0564
3M XP 505 X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
87
4908
C900 X-RAY FILM PROCESSOR
2
Cleared 510(K)
K
87
4926
KODAK REMOTE ALARM UNIT
2
Cleared 510(K)
K
86
2595
KODAK M35A X-OMAT PROCESSOR
2
Cleared 510(K)
K
86
1225
KODAK AUTOMIXER II
2
Cleared 510(K)
K
86
0666
KODAK X-OMAT PROCESSOR, MODEL ME-3
2
Cleared 510(K)
K
85
5219
KODAK RP X-OMAT PROCESSOR MODEL M6B
2
Cleared 510(K)
K
85
4219
KODAK M35 X-OMAT PROCESSOR
2
Cleared 510(K)
K
83
2603
CURIX CAPACITY FILM CENTER
2
Cleared 510(K)
K
81
2088
POLAROID RADIOGRAPHIC FILM PROCESSOR
2
Cleared 510(K)
K
80
1209
KODAK MEDICAL X-RAY DEVELOPER & REPLEN.
2
Cleared 510(K)
K
79
0121
FILM-X 90
2
Cleared 510(K)
K
78
1934
PROCESSOR, MODEL M8
2
Cleared 510(K)
K
78
0248
CRONEX QC-1 PROCESSOR
2
Cleared 510(K)
K
77
1857
AUTOMIXER, KODAK
2
Cleared 510(K)
K
76
0905
SUPERMAX AUTOMATIC X-RAY PROCESSOR
2
Cleared 510(K)
IXX
Processor, Cine Film
2
Product Code
IXY
Holder, Radiographic Cassette, Wall-Mounted
1
Product Code
IYB
Tube Mount, X-Ray, Diagnostic
1
Product Code
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
2
Product Code
IYO
System, Imaging, Pulsed Echo, Ultrasonic
2
Product Code
IYP
Phantom, Anthropomorphic, Nuclear
1
Product Code
IYQ
Phantom, Flood Source, Nuclear
1
Product Code
IYT
System, Rebreathing, Radionuclide
2
Product Code
IYW
Scanner, Rectilinear, Nuclear
1
Product Code
IYX
Camera, Scintillation (Gamma)
1
Product Code
IYY
Synchronizer, Electrocardiograph, Nuclear
1
Product Code
IYZ
Bed, Scanning, Nuclear
1
Product Code
IZC
Camera, Positron
1
Product Code
IZD
Probe, Uptake, Nuclear
1
Product Code
IZF
System, X-Ray, Tomographic
2
Product Code
IZG
System, X-Ray, Photofluorographic
2
Product Code
IZH
System, X-Ray, Mammographic
2
Product Code
IZI
System, X-Ray, Angiographic
2
Product Code
IZJ
Camera, X-Ray, Fluorographic, Cine Or Spot
2
Product Code
IZL
System, X-Ray, Mobile
2
Product Code
IZO
Generator, High-Voltage, X-Ray, Diagnostic
1
Product Code
IZP
Programmer, Changer, Film/Cassette, Radiographic
2
Product Code
IZS
Aperture, Radiographic
2
Product Code
IZT
Cone, Radiographic
2
Product Code
IZW
Collimator, Automatic, Radiographic
2
Product Code
IZX
Collimator, Manual, Radiographic
2
Product Code
IZZ
Table, Radiographic, Non-Tilting, Powered
2
Product Code
JAA
System, X-Ray, Fluoroscopic, Image-Intensified
2
Product Code
JAB
System, X-Ray, Fluoroscopic, Non-Image-Intensified
2
Product Code
JAC
System, X-Ray, Film Marking, Radiographic
1
Product Code
JAF
Monitor, Ultrasonic, Nonfetal
2
Product Code
JAG
Illuminator, Radiographic-Film, Explosion-Proof
1
Product Code
JAK
System, X-Ray, Tomography, Computed
2
Product Code
JAM
Scanner, Whole Body, Nuclear
1
Product Code
JAN
Counter, Whole Body, Nuclear
1
Product Code
JAO
Scanner, Fluorescent
2
Product Code
JAR
Phantom, Test-Pattern, Radionuclide
1
Product Code
JWM
System, Tomographic, Nuclear
2
Product Code
KGI
Densitometer, Bone
2
Product Code
KPR
System, X-Ray, Stationary
2
Product Code
KPS
System, Tomography, Computed, Emission
2
Product Code
KPT
Calibrator, Dose, Radionuclide
2
Product Code
KPW
Device, Beam Limiting, X-Ray, Diagnostic
2
Product Code
KPX
Changer, Radiographic Film/Cassette
2
Product Code
KXH
Cradle, Patient, Radiologic
1
Product Code
KXJ
Table, Radiologic
2
Product Code
LEK
Transilluminator (Diaphanoscope)
3
Product Code
LHO
Instrument, Quality-Assurance, Radiologic
1
Product Code
LLZ
System, Image Processing, Radiological
2
Product Code
LMA
Digitizer, Image, Radiological
2
Product Code
LMB
Device, Digital Image Storage, Radiological
1
Product Code
LMC
Camera, Multi Format, Radiological
2
Product Code
LMD
System, Digital Image Communications, Radiological
1
Product Code
LNH
System, Nuclear Magnetic Resonance Imaging
2
Product Code
LNI
System, Nuclear Magnetic Resonance Spectroscopic
2
Product Code
LQA
Media, Reusable Image
1
Product Code
MOS
Coil, Magnetic Resonance, Specialty
2
Product Code
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
2
Product Code
MUA
Bone Sonometer
2
Product Code
MUE
Full Field Digital, System, X-Ray, Mammographic
2
Product Code
MUI
Media, Coupling, Ultrasound
2
Product Code
MWP
Cabinet, X-Ray System
2
Product Code
MYN
Analyzer, Medical Image
2
Product Code
NCS
System, Imaging, Holography, Acoustic
2
Product Code
NWE
Colon Computed Tomography System, Computer Aided Detection
2
Product Code
OAS
X-Ray, Tomography, Computed, Dental
2
Product Code
OEB
Lung Computed Tomography System, Computer-Aided Detection
2
Product Code
OII
Arthrogram Tray
2
Product Code
OIJ
Biopsy Needle Guide Kit
2
Product Code
OIK
Radiology Dental Tray
2
Product Code
OIL
Discography Kit
2
Product Code
OIM
Mri Disposable Kit
2
Product Code
OIO
Radiographic Contrast Tray
2
Product Code
OIP
Radiology-Diagnostic Kit
2
Product Code
OMJ
Chest X-Ray Computer Aided Detection
2
Product Code
OQQ
Diagnostic Ultrasonic Transducer, Robotic
2
Product Code
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
2
Product Code
OWB
Interventional Fluoroscopic X-Ray System
2
Product Code
OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
2
Product Code
PGY
Display, Diagnostic Radiology
2
Product Code
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 9 May 2025 at 11:05 pm
RA
/
subpart-b—diagnostic-devices
/
IXW
/
K955706
View Source
JPI AUTOMATIC X-RAY FILM PROCESSOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K955706
510(k) Type
Traditional
Applicant
JPI HEALTHCARE CO., LTD
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/12/1996
Days to Decision
59 days
Submission Type
Statement
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
K
11
1167
XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT
K
09
3503
INTRAX FILM PROCESSOR
K
09
1628
OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX
K
02
4342
RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000
K
02
3801
FILM PROCESSOR, MODEL LIFE RAY PRO 1000
K
02
3825
FILM PROCESSOR, MODEL LIFE RAY PRO 2500
K
02
3613
AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
K
02
2154
LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D
K
00
2640
FREEDOM AUTOMATIC FILM PROCESSOR
K
00
2404
MICRO-MAX, MODEL 319
K
00
1321
ALL-PRO 2010
K
99
2818
OPTIMAX/ COMPACT 2
K
99
0969
KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR
K
99
1435
AII-PRO 100 PLUS AND ALL-PRO 200
K
98
1280
CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS
K
97
3125
MAMMOLOADER BY C.M.A. SRL
K
97
0059
KODAK MINILOADER(2000)
K
96
2750
3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR
K
95
5706
JPI AUTOMATIC X-RAY FILM PROCESSOR
K
95
1373
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ
K
95
4484
KODAK AUTOMIXER II PLUS
K
95
4345
DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR
K
95
1397
KODAK X-OMAT 5000 RA PROCESSOR
K
95
1396
KODAK X-OMAT 3000 RA PROCESSOR
K
94
4046
FUJI COMPUTED RADIOGRAPHY SYSTEMS
K
95
0043
JPI AUTOMATIC X-RAY FILM PROCESSOR
K
94
0112
X-RAY FILM PROCESSOR
K
95
0358
KONICA SRX-201 AUTOMATIC X-RA FILM PROCESSOR
K
94
0540
VELO ACE
K
94
0558
3M XP-2000 X-RAY FILM PROCESSOR
K
93
4350
KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS
K
93
5957
FUJI MEDICAL FILM PROCESSOR FPM2800
K
93
1316
KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSOR
K
93
1315
KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR
K
93
1317
KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR
K
93
3001
KODAK XML 300 DARKROOM FILM FEEDER
K
93
1313
KONICA QX-130APLUS AUTOMATIC X-RAY FILM PROCESSOR
K
93
1314
KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSOR
K
93
1312
KONICA SRX-101 AUTOMATIC X-RAY FILM PROCESSOR
K
93
1882
MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR
K
93
1883
AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033
K
93
3408
FUJI DAYLIGHT CASSETTE MULTI-LOADER
K
92
5885
AFP 17 X 4 AUTOMATIC FILM PROCESSOR
K
92
3554
KODAK EKTASCAN
K
92
5569
AX-700LE AUTOMATIC X-RAY FILM PROCESSOR
K
92
4552
DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II)
K
92
4430
AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027
K
92
3552
KODAK X-OMAT FS-1A PROCESSOR
K
92
1269
KODAK X-OMAT MODEL 180 LP PROCESSOR
K
92
0715
KODAK X-OMAT FIXER MANAGER
K
91
4143
KODAK X-OMAT 480 RA PROCESSOR
K
91
3354
KODAK EKTASCAN STORAGE PHOSPHOR READER MODEL 1A
K
91
2225
3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT
K
91
1291
ALL-PRO 100
K
91
1711
KODAK AUTOMATIC FILM FEEDER, MODEL RA
K
91
1713
KODAK 100-J & 100-K CHEMICAL MIXERS
K
91
1714
KODAK M35-MX-0MAT PROCESSOR
K
90
5607
KODAK X-OMAT MULTILOADER 300
K
90
4238
KODAK X-MAT 270 RA PROCESSOR
K
90
2732
KODAK X-OMAT 460 RA PROCESSOR
K
90
1772
KODAK M35A-M X-OMAT PROCESSOR
K
89
0486
MXR-14 FILM PROCESSOR
K
88
5207
KODAK MULTILOADER 700
K
88
2320
KODAK EKTASCAN LASER PRINTER ADAPTER, MODEL M6/M8
K
88
1248
KODAK AUTOMATIC FILM FEEDER, MODEL 11
K
88
0563
3M XP515 X-RAY FILM PROCESSOR
K
88
0565
3M TRIMATIC M MODULAR SYSTEM AND ACCESSORIES
K
88
0564
3M XP 505 X-RAY FILM PROCESSOR
K
87
4908
C900 X-RAY FILM PROCESSOR
K
87
4926
KODAK REMOTE ALARM UNIT
K
86
2595
KODAK M35A X-OMAT PROCESSOR
K
86
1225
KODAK AUTOMIXER II
K
86
0666
KODAK X-OMAT PROCESSOR, MODEL ME-3
K
85
5219
KODAK RP X-OMAT PROCESSOR MODEL M6B
K
85
4219
KODAK M35 X-OMAT PROCESSOR
K
83
2603
CURIX CAPACITY FILM CENTER
K
81
2088
POLAROID RADIOGRAPHIC FILM PROCESSOR
K
80
1209
KODAK MEDICAL X-RAY DEVELOPER & REPLEN.
K
79
0121
FILM-X 90
K
78
1934
PROCESSOR, MODEL M8
K
78
0248
CRONEX QC-1 PROCESSOR
K
77
1857
AUTOMIXER, KODAK
K
76
0905
SUPERMAX AUTOMATIC X-RAY PROCESSOR
IXX
Processor, Cine Film
IXY
Holder, Radiographic Cassette, Wall-Mounted
IYB
Tube Mount, X-Ray, Diagnostic
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
IYO
System, Imaging, Pulsed Echo, Ultrasonic
IYP
Phantom, Anthropomorphic, Nuclear
IYQ
Phantom, Flood Source, Nuclear
IYT
System, Rebreathing, Radionuclide
IYW
Scanner, Rectilinear, Nuclear
IYX
Camera, Scintillation (Gamma)
IYY
Synchronizer, Electrocardiograph, Nuclear
IYZ
Bed, Scanning, Nuclear
IZC
Camera, Positron
IZD
Probe, Uptake, Nuclear
IZF
System, X-Ray, Tomographic
IZG
System, X-Ray, Photofluorographic
IZH
System, X-Ray, Mammographic
IZI
System, X-Ray, Angiographic
IZJ
Camera, X-Ray, Fluorographic, Cine Or Spot
IZL
System, X-Ray, Mobile
IZO
Generator, High-Voltage, X-Ray, Diagnostic
IZP
Programmer, Changer, Film/Cassette, Radiographic
IZS
Aperture, Radiographic
IZT
Cone, Radiographic
IZW
Collimator, Automatic, Radiographic
IZX
Collimator, Manual, Radiographic
IZZ
Table, Radiographic, Non-Tilting, Powered
JAA
System, X-Ray, Fluoroscopic, Image-Intensified
JAB
System, X-Ray, Fluoroscopic, Non-Image-Intensified
JAC
System, X-Ray, Film Marking, Radiographic
JAF
Monitor, Ultrasonic, Nonfetal
JAG
Illuminator, Radiographic-Film, Explosion-Proof
JAK
System, X-Ray, Tomography, Computed
JAM
Scanner, Whole Body, Nuclear
JAN
Counter, Whole Body, Nuclear
JAO
Scanner, Fluorescent
JAR
Phantom, Test-Pattern, Radionuclide
JWM
System, Tomographic, Nuclear
KGI
Densitometer, Bone
KPR
System, X-Ray, Stationary
KPS
System, Tomography, Computed, Emission
KPT
Calibrator, Dose, Radionuclide
KPW
Device, Beam Limiting, X-Ray, Diagnostic
KPX
Changer, Radiographic Film/Cassette
KXH
Cradle, Patient, Radiologic
KXJ
Table, Radiologic
LEK
Transilluminator (Diaphanoscope)
LHO
Instrument, Quality-Assurance, Radiologic
LLZ
System, Image Processing, Radiological
LMA
Digitizer, Image, Radiological
LMB
Device, Digital Image Storage, Radiological
LMC
Camera, Multi Format, Radiological
LMD
System, Digital Image Communications, Radiological
LNH
System, Nuclear Magnetic Resonance Imaging
LNI
System, Nuclear Magnetic Resonance Spectroscopic
LQA
Media, Reusable Image
MOS
Coil, Magnetic Resonance, Specialty
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
MUA
Bone Sonometer
MUE
Full Field Digital, System, X-Ray, Mammographic
MUI
Media, Coupling, Ultrasound
MWP
Cabinet, X-Ray System
MYN
Analyzer, Medical Image
NCS
System, Imaging, Holography, Acoustic
NWE
Colon Computed Tomography System, Computer Aided Detection
OAS
X-Ray, Tomography, Computed, Dental
OEB
Lung Computed Tomography System, Computer-Aided Detection
OII
Arthrogram Tray
OIJ
Biopsy Needle Guide Kit
OIK
Radiology Dental Tray
OIL
Discography Kit
OIM
Mri Disposable Kit
OIO
Radiographic Contrast Tray
OIP
Radiology-Diagnostic Kit
OMJ
Chest X-Ray Computer Aided Detection
OQQ
Diagnostic Ultrasonic Transducer, Robotic
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
OWB
Interventional Fluoroscopic X-Ray System
OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
PGY
Display, Diagnostic Radiology
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
/
IXW
/
K955706
View Source
JPI AUTOMATIC X-RAY FILM PROCESSOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K955706
510(k) Type
Traditional
Applicant
JPI HEALTHCARE CO., LTD
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/12/1996
Days to Decision
59 days
Submission Type
Statement