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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
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Pathology
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Physical Medicine
Review Panel
Radiology
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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
K
08
1557
PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER
2
Cleared 510(K)
K
05
3173
DS CASSETTE
2
Cleared 510(K)
K
04
0378
KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253
2
Cleared 510(K)
K
02
3020
AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE
2
Cleared 510(K)
K
02
1903
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
2
Cleared 510(K)
K
01
3686
KODAK DIRECTVIEW TABLETOP CASSETTE
2
Cleared 510(K)
K
01
3229
LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE
2
Cleared 510(K)
K
01
2373
LIFERAY WL CASSETTE, LIFERAY KW CASSETTE
2
Cleared 510(K)
K
98
3918
RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)
2
Cleared 510(K)
K
98
0722
TRIMAX RADIOGRAPHIC CASSETTE
2
Cleared 510(K)
K
96
3914
CM & CM DS-7
2
Cleared 510(K)
K
97
1431
UMI X-RAY FILM CASSETTE
2
Cleared 510(K)
K
97
0090
SOLO-SLED
2
Cleared 510(K)
K
96
1453
KODAK MN-R 2000 CASSETTE
2
Cleared 510(K)
K
96
2336
RADIOGRAPHIC FILM CASSETTES
2
Cleared 510(K)
K
95
3725
CRONEX RADIATION THERAPY VERIFICATION CASSETTE
2
Cleared 510(K)
K
95
3724
CRONEX RADIATION THERAPY CASSETTE
2
Cleared 510(K)
K
95
3444
MCI OPTONIX ECONOMY CASSETTE
2
Cleared 510(K)
K
95
2891
CRONEX LOW ABSORPTION CASSETTE
2
Cleared 510(K)
K
95
1006
KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)
2
Cleared 510(K)
K
94
5858
X-RAY FILM CASSETTE
2
Cleared 510(K)
K
94
5328
JPI X-RAY FILM CASSETTE
2
Cleared 510(K)
K
94
5039
MCI OPTONIX CASSETTE OKAMOTO CASSETE
2
Cleared 510(K)
K
94
1600
MT-300 CASSETTE HOLDER
2
Cleared 510(K)
K
94
2481
FUJI ULTIMA EC-MA CASSETTE
2
Cleared 510(K)
K
94
1475
CRONEX REGULAR CASSETTE
2
Cleared 510(K)
K
94
1518
DUPONT CRONEX PORTABLE GRID CASSETTE
2
Cleared 510(K)
K
93
5397
NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY CASSETTE HOLDERS
2
Cleared 510(K)
K
93
2565
FUJIFILM EC-B SERIES CASETTE
2
Cleared 510(K)
K
93
1074
DU PONT MV DARKROOM CASSETTE
2
Cleared 510(K)
K
93
0220
CASSETTE, RADIOGRAPHIC FILM
2
Cleared 510(K)
K
93
0244
JPI X-RAY FILM CASSETTE
2
Cleared 510(K)
K
92
3334
MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER
2
Cleared 510(K)
K
92
1826
KODAK INSIGHT PORTABLE IMAGING SYSTEM
2
Cleared 510(K)
K
91
1041
INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE
2
Cleared 510(K)
K
89
6708
PERLINK CASSETTE, KIRAN CASSETTE
2
Cleared 510(K)
K
90
1013
RADIOGRAPHIC FILM CASSETTE
2
Cleared 510(K)
K
90
0620
DU PONT MAMMOGRAPHY CASSETTE
2
Cleared 510(K)
K
89
5335
CRONEX COMPACT MAMMOGRAPHY CASSETTE
2
Cleared 510(K)
K
89
3728
PINK CASSETTE CADDIE
2
Cleared 510(K)
K
89
0750
KODAK X-OMATIC RA CASSETTE
2
Cleared 510(K)
K
89
0361
KODAK MIN-R 2 CASSETTE
2
Cleared 510(K)
K
88
5178
KODAFLEX II RADIATION THERAPY L CASSETTE
2
Cleared 510(K)
K
88
3312
L-F/KODAK FLEXIBLE GRID CASSETTE
2
Cleared 510(K)
K
87
5083
KODAK KODAFLEX II CASSETTE
2
Cleared 510(K)
K
86
0754
KODAK T-MAT M FILM SO-245
2
Cleared 510(K)
K
85
0415
CRONEX KEVLAR CASSETTE
2
Cleared 510(K)
K
84
3176
KODAK X-OMATIC RADIATION THERAPY CASS
2
Cleared 510(K)
K
81
2535
PLASTILIX MINIRAD D CASSETTE
2
Cleared 510(K)
K
79
2721
HUESTIS FLEXI-HOLDER
2
Cleared 510(K)
K
77
1682
MIN-R CASSETTE
2
Cleared 510(K)
IXC
Illuminator, Radiographic-Film
1
Product Code
IXD
Source, Calibration, Sealed, Nuclear
1
Product Code
IXF
Test-Pattern, Radiographic
1
Product Code
IXG
Phantom, Anthropomorphic, Radiographic
1
Product Code
IXH
Camera, Focal Spot, Radiographic
1
Product Code
IXJ
Grid, Radiographic
1
Product Code
IXK
System, Imaging, X-Ray, Electrostatic
2
Product Code
IXL
Device, Spot-Film
2
Product Code
IXO
Synchronizer, Ecg / Respirator, Radiographic
1
Product Code
IXQ
Table, Radiographic, Stationary Top
2
Product Code
IXR
Table, Radiographic, Tilting
2
Product Code
IXW
Processor, Radiographic-Film, Automatic
2
Product Code
IXX
Processor, Cine Film
2
Product Code
IXY
Holder, Radiographic Cassette, Wall-Mounted
1
Product Code
IYB
Tube Mount, X-Ray, Diagnostic
1
Product Code
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
2
Product Code
IYO
System, Imaging, Pulsed Echo, Ultrasonic
2
Product Code
IYP
Phantom, Anthropomorphic, Nuclear
1
Product Code
IYQ
Phantom, Flood Source, Nuclear
1
Product Code
IYT
System, Rebreathing, Radionuclide
2
Product Code
IYW
Scanner, Rectilinear, Nuclear
1
Product Code
IYX
Camera, Scintillation (Gamma)
1
Product Code
IYY
Synchronizer, Electrocardiograph, Nuclear
1
Product Code
IYZ
Bed, Scanning, Nuclear
1
Product Code
IZC
Camera, Positron
1
Product Code
IZD
Probe, Uptake, Nuclear
1
Product Code
IZF
System, X-Ray, Tomographic
2
Product Code
IZG
System, X-Ray, Photofluorographic
2
Product Code
IZH
System, X-Ray, Mammographic
2
Product Code
IZI
System, X-Ray, Angiographic
2
Product Code
IZJ
Camera, X-Ray, Fluorographic, Cine Or Spot
2
Product Code
IZL
System, X-Ray, Mobile
2
Product Code
IZO
Generator, High-Voltage, X-Ray, Diagnostic
1
Product Code
IZP
Programmer, Changer, Film/Cassette, Radiographic
2
Product Code
IZS
Aperture, Radiographic
2
Product Code
IZT
Cone, Radiographic
2
Product Code
IZW
Collimator, Automatic, Radiographic
2
Product Code
IZX
Collimator, Manual, Radiographic
2
Product Code
IZZ
Table, Radiographic, Non-Tilting, Powered
2
Product Code
JAA
System, X-Ray, Fluoroscopic, Image-Intensified
2
Product Code
JAB
System, X-Ray, Fluoroscopic, Non-Image-Intensified
2
Product Code
JAC
System, X-Ray, Film Marking, Radiographic
1
Product Code
JAF
Monitor, Ultrasonic, Nonfetal
2
Product Code
JAG
Illuminator, Radiographic-Film, Explosion-Proof
1
Product Code
JAK
System, X-Ray, Tomography, Computed
2
Product Code
JAM
Scanner, Whole Body, Nuclear
1
Product Code
JAN
Counter, Whole Body, Nuclear
1
Product Code
JAO
Scanner, Fluorescent
2
Product Code
JAR
Phantom, Test-Pattern, Radionuclide
1
Product Code
JWM
System, Tomographic, Nuclear
2
Product Code
KGI
Densitometer, Bone
2
Product Code
KPR
System, X-Ray, Stationary
2
Product Code
KPS
System, Tomography, Computed, Emission
2
Product Code
KPT
Calibrator, Dose, Radionuclide
2
Product Code
KPW
Device, Beam Limiting, X-Ray, Diagnostic
2
Product Code
KPX
Changer, Radiographic Film/Cassette
2
Product Code
KXH
Cradle, Patient, Radiologic
1
Product Code
KXJ
Table, Radiologic
2
Product Code
LEK
Transilluminator (Diaphanoscope)
3
Product Code
LHO
Instrument, Quality-Assurance, Radiologic
1
Product Code
LLZ
System, Image Processing, Radiological
2
Product Code
LMA
Digitizer, Image, Radiological
2
Product Code
LMB
Device, Digital Image Storage, Radiological
1
Product Code
LMC
Camera, Multi Format, Radiological
2
Product Code
LMD
System, Digital Image Communications, Radiological
1
Product Code
LNH
System, Nuclear Magnetic Resonance Imaging
2
Product Code
LNI
System, Nuclear Magnetic Resonance Spectroscopic
2
Product Code
LQA
Media, Reusable Image
1
Product Code
MOS
Coil, Magnetic Resonance, Specialty
2
Product Code
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
2
Product Code
MUA
Bone Sonometer
2
Product Code
MUE
Full Field Digital, System, X-Ray, Mammographic
2
Product Code
MUI
Media, Coupling, Ultrasound
2
Product Code
MWP
Cabinet, X-Ray System
2
Product Code
MYN
Analyzer, Medical Image
2
Product Code
NCS
System, Imaging, Holography, Acoustic
2
Product Code
NWE
Colon Computed Tomography System, Computer Aided Detection
2
Product Code
OAS
X-Ray, Tomography, Computed, Dental
2
Product Code
OEB
Lung Computed Tomography System, Computer-Aided Detection
2
Product Code
OII
Arthrogram Tray
2
Product Code
OIJ
Biopsy Needle Guide Kit
2
Product Code
OIK
Radiology Dental Tray
2
Product Code
OIL
Discography Kit
2
Product Code
OIM
Mri Disposable Kit
2
Product Code
OIO
Radiographic Contrast Tray
2
Product Code
OIP
Radiology-Diagnostic Kit
2
Product Code
OMJ
Chest X-Ray Computer Aided Detection
2
Product Code
OQQ
Diagnostic Ultrasonic Transducer, Robotic
2
Product Code
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
2
Product Code
OWB
Interventional Fluoroscopic X-Ray System
2
Product Code
OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
2
Product Code
PGY
Display, Diagnostic Radiology
2
Product Code
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 18 April 2025 at 11:05 pm
RA
/
subpart-b—diagnostic-devices
/
IXA
/
K883312
View Source
L-F/KODAK FLEXIBLE GRID CASSETTE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K883312
510(k) Type
Traditional
Applicant
MALLINCKRODT GROUP, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/16/1988
Days to Decision
11 days
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
K
08
1557
PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER
K
05
3173
DS CASSETTE
K
04
0378
KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253
K
02
3020
AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE
K
02
1903
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
K
01
3686
KODAK DIRECTVIEW TABLETOP CASSETTE
K
01
3229
LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE
K
01
2373
LIFERAY WL CASSETTE, LIFERAY KW CASSETTE
K
98
3918
RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)
K
98
0722
TRIMAX RADIOGRAPHIC CASSETTE
K
96
3914
CM & CM DS-7
K
97
1431
UMI X-RAY FILM CASSETTE
K
97
0090
SOLO-SLED
K
96
1453
KODAK MN-R 2000 CASSETTE
K
96
2336
RADIOGRAPHIC FILM CASSETTES
K
95
3725
CRONEX RADIATION THERAPY VERIFICATION CASSETTE
K
95
3724
CRONEX RADIATION THERAPY CASSETTE
K
95
3444
MCI OPTONIX ECONOMY CASSETTE
K
95
2891
CRONEX LOW ABSORPTION CASSETTE
K
95
1006
KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)
K
94
5858
X-RAY FILM CASSETTE
K
94
5328
JPI X-RAY FILM CASSETTE
K
94
5039
MCI OPTONIX CASSETTE OKAMOTO CASSETE
K
94
1600
MT-300 CASSETTE HOLDER
K
94
2481
FUJI ULTIMA EC-MA CASSETTE
K
94
1475
CRONEX REGULAR CASSETTE
K
94
1518
DUPONT CRONEX PORTABLE GRID CASSETTE
K
93
5397
NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY CASSETTE HOLDERS
K
93
2565
FUJIFILM EC-B SERIES CASETTE
K
93
1074
DU PONT MV DARKROOM CASSETTE
K
93
0220
CASSETTE, RADIOGRAPHIC FILM
K
93
0244
JPI X-RAY FILM CASSETTE
K
92
3334
MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER
K
92
1826
KODAK INSIGHT PORTABLE IMAGING SYSTEM
K
91
1041
INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE
K
89
6708
PERLINK CASSETTE, KIRAN CASSETTE
K
90
1013
RADIOGRAPHIC FILM CASSETTE
K
90
0620
DU PONT MAMMOGRAPHY CASSETTE
K
89
5335
CRONEX COMPACT MAMMOGRAPHY CASSETTE
K
89
3728
PINK CASSETTE CADDIE
K
89
0750
KODAK X-OMATIC RA CASSETTE
K
89
0361
KODAK MIN-R 2 CASSETTE
K
88
5178
KODAFLEX II RADIATION THERAPY L CASSETTE
K
88
3312
L-F/KODAK FLEXIBLE GRID CASSETTE
K
87
5083
KODAK KODAFLEX II CASSETTE
K
86
0754
KODAK T-MAT M FILM SO-245
K
85
0415
CRONEX KEVLAR CASSETTE
K
84
3176
KODAK X-OMATIC RADIATION THERAPY CASS
K
81
2535
PLASTILIX MINIRAD D CASSETTE
K
79
2721
HUESTIS FLEXI-HOLDER
K
77
1682
MIN-R CASSETTE
IXC
Illuminator, Radiographic-Film
IXD
Source, Calibration, Sealed, Nuclear
IXF
Test-Pattern, Radiographic
IXG
Phantom, Anthropomorphic, Radiographic
IXH
Camera, Focal Spot, Radiographic
IXJ
Grid, Radiographic
IXK
System, Imaging, X-Ray, Electrostatic
IXL
Device, Spot-Film
IXO
Synchronizer, Ecg / Respirator, Radiographic
IXQ
Table, Radiographic, Stationary Top
IXR
Table, Radiographic, Tilting
IXW
Processor, Radiographic-Film, Automatic
IXX
Processor, Cine Film
IXY
Holder, Radiographic Cassette, Wall-Mounted
IYB
Tube Mount, X-Ray, Diagnostic
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
IYO
System, Imaging, Pulsed Echo, Ultrasonic
IYP
Phantom, Anthropomorphic, Nuclear
IYQ
Phantom, Flood Source, Nuclear
IYT
System, Rebreathing, Radionuclide
IYW
Scanner, Rectilinear, Nuclear
IYX
Camera, Scintillation (Gamma)
IYY
Synchronizer, Electrocardiograph, Nuclear
IYZ
Bed, Scanning, Nuclear
IZC
Camera, Positron
IZD
Probe, Uptake, Nuclear
IZF
System, X-Ray, Tomographic
IZG
System, X-Ray, Photofluorographic
IZH
System, X-Ray, Mammographic
IZI
System, X-Ray, Angiographic
IZJ
Camera, X-Ray, Fluorographic, Cine Or Spot
IZL
System, X-Ray, Mobile
IZO
Generator, High-Voltage, X-Ray, Diagnostic
IZP
Programmer, Changer, Film/Cassette, Radiographic
IZS
Aperture, Radiographic
IZT
Cone, Radiographic
IZW
Collimator, Automatic, Radiographic
IZX
Collimator, Manual, Radiographic
IZZ
Table, Radiographic, Non-Tilting, Powered
JAA
System, X-Ray, Fluoroscopic, Image-Intensified
JAB
System, X-Ray, Fluoroscopic, Non-Image-Intensified
JAC
System, X-Ray, Film Marking, Radiographic
JAF
Monitor, Ultrasonic, Nonfetal
JAG
Illuminator, Radiographic-Film, Explosion-Proof
JAK
System, X-Ray, Tomography, Computed
JAM
Scanner, Whole Body, Nuclear
JAN
Counter, Whole Body, Nuclear
JAO
Scanner, Fluorescent
JAR
Phantom, Test-Pattern, Radionuclide
JWM
System, Tomographic, Nuclear
KGI
Densitometer, Bone
KPR
System, X-Ray, Stationary
KPS
System, Tomography, Computed, Emission
KPT
Calibrator, Dose, Radionuclide
KPW
Device, Beam Limiting, X-Ray, Diagnostic
KPX
Changer, Radiographic Film/Cassette
KXH
Cradle, Patient, Radiologic
KXJ
Table, Radiologic
LEK
Transilluminator (Diaphanoscope)
LHO
Instrument, Quality-Assurance, Radiologic
LLZ
System, Image Processing, Radiological
LMA
Digitizer, Image, Radiological
LMB
Device, Digital Image Storage, Radiological
LMC
Camera, Multi Format, Radiological
LMD
System, Digital Image Communications, Radiological
LNH
System, Nuclear Magnetic Resonance Imaging
LNI
System, Nuclear Magnetic Resonance Spectroscopic
LQA
Media, Reusable Image
MOS
Coil, Magnetic Resonance, Specialty
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
MUA
Bone Sonometer
MUE
Full Field Digital, System, X-Ray, Mammographic
MUI
Media, Coupling, Ultrasound
MWP
Cabinet, X-Ray System
MYN
Analyzer, Medical Image
NCS
System, Imaging, Holography, Acoustic
NWE
Colon Computed Tomography System, Computer Aided Detection
OAS
X-Ray, Tomography, Computed, Dental
OEB
Lung Computed Tomography System, Computer-Aided Detection
OII
Arthrogram Tray
OIJ
Biopsy Needle Guide Kit
OIK
Radiology Dental Tray
OIL
Discography Kit
OIM
Mri Disposable Kit
OIO
Radiographic Contrast Tray
OIP
Radiology-Diagnostic Kit
OMJ
Chest X-Ray Computer Aided Detection
OQQ
Diagnostic Ultrasonic Transducer, Robotic
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
OWB
Interventional Fluoroscopic X-Ray System
OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
PGY
Display, Diagnostic Radiology
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
/
IXA
/
K883312
View Source
L-F/KODAK FLEXIBLE GRID CASSETTE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K883312
510(k) Type
Traditional
Applicant
MALLINCKRODT GROUP, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/16/1988
Days to Decision
11 days