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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
K
13
2183
DICOM VIDEO
2
Cleared 510(K)
K
13
0636
TELERADPRO EDGE; TELERADPRO EDGE HD-CCD
2
Cleared 510(K)
K
13
0406
DIAGNOSTICPRO EDGE
2
Cleared 510(K)
K
10
2476
TELERADPRO
2
Cleared 510(K)
K
09
3809
VIDAR DENTAL FILM DIGITIZER
2
Cleared 510(K)
K
09
1288
MEDI-6000 MEDICAL IMAGE DIGITIZER
2
Cleared 510(K)
K
06
3424
FILM DIGITZER, MODEL 2908 MAMMO PRO
2
Cleared 510(K)
K
04
2484
NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER
2
Cleared 510(K)
K
03
3637
MEDICAL IMAGE DIGITIZER, MODEL 2908
2
Cleared 510(K)
K
03
2022
DIGITAL IMAGER
2
Cleared 510(K)
K
02
2810
COBRASCAN CR-1 FILMLESS
2
Cleared 510(K)
K
02
1949
FULCRUM
2
Cleared 510(K)
K
02
0243
LASERPRO 16
2
Cleared 510(K)
K
01
3631
EFILM VIDEO
2
Cleared 510(K)
K
01
3395
LIFEJET VIDEO LINK
2
Cleared 510(K)
K
01
1049
EXPRESSSUITE
2
Cleared 510(K)
K
00
1841
35/CD CINECONVERTER
2
Cleared 510(K)
K
00
0411
CHILI VIDEO, CHILI VIDEOPRO
2
Cleared 510(K)
K
99
2467
IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM
2
Cleared 510(K)
K
99
3598
MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205
2
Cleared 510(K)
K
99
3599
DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019
2
Cleared 510(K)
K
99
3597
PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617
2
Cleared 510(K)
K
99
0066
CCD CAMERA, MODEL 9000
2
Cleared 510(K)
K
98
4409
ELK LASER FILM DIGITIZER
2
Cleared 510(K)
K
98
4252
IMATION TRIMATIC DIGITAL SYSTEM
2
Cleared 510(K)
K
98
2785
FILM DIGITIZER MODEL 2905
2
Cleared 510(K)
K
98
0873
KONICA DIRECT DIGITIZER REGIUS MODEL 330
2
Cleared 510(K)
K
98
0809
LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER
2
Cleared 510(K)
K
97
4315
VIDAR VXR LS LASER FILM DIGITIZER
2
Cleared 510(K)
K
98
0565
LD2000 SERIES
2
Cleared 510(K)
K
98
0213
DI-2000
2
Cleared 510(K)
K
97
4619
SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM
2
Cleared 510(K)
K
97
3411
DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)
2
Cleared 510(K)
K
97
1894
KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM
2
Cleared 510(K)
K
97
0908
HOWTEK 960
2
Cleared 510(K)
K
96
4288
CALL-RAD PC TELERADIOLOGY
2
Cleared 510(K)
K
96
0839
FILM SCANNER 300
2
Cleared 510(K)
K
96
1768
KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER)
2
Cleared 510(K)
K
95
3117
SCANMASTER DX
2
Cleared 510(K)
K
95
4875
ASPECT ACQUISITION MODULE (AAM)
2
Cleared 510(K)
K
95
3942
COBRASCAN CX-312
2
Cleared 510(K)
K
95
2485
LASERNET IMAGE MANAGER/PRINT SERVER
2
Cleared 510(K)
K
95
3964
LUMISYS, LUMISCAN 20
2
Cleared 510(K)
K
94
3357
CEMAX SCANLINK V
2
Cleared 510(K)
K
93
2760
DFS-2100
2
Cleared 510(K)
K
92
5799
AD/V A.5
2
Cleared 510(K)
K
93
3830
KONICA LD-4500 LASER DIGITIZER
2
Cleared 510(K)
K
93
3632
MEDSCAN 12
2
Cleared 510(K)
K
93
3129
LUMISCAN 50
2
Cleared 510(K)
K
92
5721
KODAK EKTASCAN CP PRIMARY HIGH FREQ. VID.INTERFACE
2
Cleared 510(K)
K
92
4478
MTV-250A, MTV-300A
2
Cleared 510(K)
K
91
1082
REAL TIME X-RAY IMAGING SYSTEM
2
Cleared 510(K)
K
90
1423
DIGITAL IMAGE SCANNER, MODEL DIS-1000
2
Cleared 510(K)
K
89
6739
KONICA KFDR-S
2
Cleared 510(K)
K
89
6223
PHOTOPHONE
2
Cleared 510(K)
K
89
4412
RADIOSCOPE OR MAMMOSCOPE
2
Cleared 510(K)
K
89
0970
TRUVEL TZ-3X X-RAY DIGITIZING SCANNER
2
Cleared 510(K)
K
89
0477
THE SPANTRON FRAME FREEZE
2
Cleared 510(K)
K
87
4778
KODAK EKTASCAN IMAGE TRANSMISSION SYST T1/R1 SFTWR
2
Cleared 510(K)
K
86
0777
MATRIX LD & LD/LASER DIGITIZER
2
Cleared 510(K)
K
85
0330
ANGIOTEC SC 1221 SCAN CONVERTER
2
Cleared 510(K)
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 6 December 2024 at 11:05 pm
RA
/
subpart-b—diagnostic-devices
/
LMA
/
K890477
View Source
THE SPANTRON FRAME FREEZE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K890477
510(k) Type
Traditional
Applicant
SPANTRON, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/31/1989
Days to Decision
59 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
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
K
13
2183
DICOM VIDEO
K
13
0636
TELERADPRO EDGE; TELERADPRO EDGE HD-CCD
K
13
0406
DIAGNOSTICPRO EDGE
K
10
2476
TELERADPRO
K
09
3809
VIDAR DENTAL FILM DIGITIZER
K
09
1288
MEDI-6000 MEDICAL IMAGE DIGITIZER
K
06
3424
FILM DIGITZER, MODEL 2908 MAMMO PRO
K
04
2484
NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER
K
03
3637
MEDICAL IMAGE DIGITIZER, MODEL 2908
K
03
2022
DIGITAL IMAGER
K
02
2810
COBRASCAN CR-1 FILMLESS
K
02
1949
FULCRUM
K
02
0243
LASERPRO 16
K
01
3631
EFILM VIDEO
K
01
3395
LIFEJET VIDEO LINK
K
01
1049
EXPRESSSUITE
K
00
1841
35/CD CINECONVERTER
K
00
0411
CHILI VIDEO, CHILI VIDEOPRO
K
99
2467
IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM
K
99
3598
MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205
K
99
3599
DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019
K
99
3597
PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617
K
99
0066
CCD CAMERA, MODEL 9000
K
98
4409
ELK LASER FILM DIGITIZER
K
98
4252
IMATION TRIMATIC DIGITAL SYSTEM
K
98
2785
FILM DIGITIZER MODEL 2905
K
98
0873
KONICA DIRECT DIGITIZER REGIUS MODEL 330
K
98
0809
LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER
K
97
4315
VIDAR VXR LS LASER FILM DIGITIZER
K
98
0565
LD2000 SERIES
K
98
0213
DI-2000
K
97
4619
SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM
K
97
3411
DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)
K
97
1894
KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM
K
97
0908
HOWTEK 960
K
96
4288
CALL-RAD PC TELERADIOLOGY
K
96
0839
FILM SCANNER 300
K
96
1768
KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER)
K
95
3117
SCANMASTER DX
K
95
4875
ASPECT ACQUISITION MODULE (AAM)
K
95
3942
COBRASCAN CX-312
K
95
2485
LASERNET IMAGE MANAGER/PRINT SERVER
K
95
3964
LUMISYS, LUMISCAN 20
K
94
3357
CEMAX SCANLINK V
K
93
2760
DFS-2100
K
92
5799
AD/V A.5
K
93
3830
KONICA LD-4500 LASER DIGITIZER
K
93
3632
MEDSCAN 12
K
93
3129
LUMISCAN 50
K
92
5721
KODAK EKTASCAN CP PRIMARY HIGH FREQ. VID.INTERFACE
K
92
4478
MTV-250A, MTV-300A
K
91
1082
REAL TIME X-RAY IMAGING SYSTEM
K
90
1423
DIGITAL IMAGE SCANNER, MODEL DIS-1000
K
89
6739
KONICA KFDR-S
K
89
6223
PHOTOPHONE
K
89
4412
RADIOSCOPE OR MAMMOSCOPE
K
89
0970
TRUVEL TZ-3X X-RAY DIGITIZING SCANNER
K
89
0477
THE SPANTRON FRAME FREEZE
K
87
4778
KODAK EKTASCAN IMAGE TRANSMISSION SYST T1/R1 SFTWR
K
86
0777
MATRIX LD & LD/LASER DIGITIZER
K
85
0330
ANGIOTEC SC 1221 SCAN CONVERTER
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
/
LMA
/
K890477
View Source
THE SPANTRON FRAME FREEZE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K890477
510(k) Type
Traditional
Applicant
SPANTRON, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/31/1989
Days to Decision
59 days