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
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
K
24
0003
Velmeni for Dentists (V4D)
2
Cleared 510(K)
K
23
3738
Overjet Caries Assist-Pediatric
2
Cleared 510(K)
K
23
1805
qXR-LN
2
Cleared 510(K)
K
23
2384
Videa Dental Assist
2
Cleared 510(K)
K
23
0144
Denti.AI Detect
2
Cleared 510(K)
K
23
1001
DeepTek CXR Analyzer v1.0
2
Cleared 510(K)
K
23
0085
Lung-CAD
2
Cleared 510(K)
K
23
1678
Overjet Periapical Radiolucency Assist
2
Cleared 510(K)
K
22
3811
Lung-CAD
2
Cleared 510(K)
K
22
3133
VisiRad XR
2
Cleared 510(K)
K
22
1921
DTX Studio Clinic 3.0
2
Cleared 510(K)
K
22
2746
Overjet Caries Assist
2
Cleared 510(K)
K
22
0928
Overjet Calculus Assist
2
Cleared 510(K)
K
21
3353
Aorta-CAD
2
Cleared 510(K)
K
21
2519
Overjet Caries Assist
2
Cleared 510(K)
K
21
3795
Videa Caries Assist
2
Cleared 510(K)
K
21
0365
Second Opinion
2
Cleared 510(K)
K
20
1560
Auto Lung Nodule Detection
2
Cleared 510(K)
K
21
0666
Chest-CAD
2
Cleared 510(K)
P
98
0025
Logicon Caries Detection Software
2
PMA Approval
P
15
0043
QVCAD System (Version 3.3)
2
PMA Approval
P
16
0009
PowerLook® Tomo Detection Software
2
PMA Approval
P
10
0005
M-VU ALGORITHM ENGINE
2
PMA Approval
P
15
0043
QVCAD SYSTEM
2
PMA Approval
P
97
0058
IMAGE CHECKER, IMAGE CHECKER LICENSE
2
PMA Approval
P
98
0025
LOGICON CARIES DETECTOR
2
PMA Approval
P
12
0004
PARASCRIPT (R) ACCUDETECT (R)
2
PMA Approval
P
10
0005
M-VU ALGORITHM ENGINE
2
PMA Approval
P
98
0025
LOGICON CARIES DETECTOR
2
PMA Approval
P
10
0005
M-VU ALGORITHM ENGINE
2
PMA Approval
P
97
0058
IMAGE CHECKER CAD
2
PMA Approval
P
10
0005
M-VU ALGORITHM ENGINE
2
PMA Approval
P
12
0004
PARASCRIPT ACCUDETECT 6.1.0
2
PMA Approval
P
10
0005
M-VU ALGORITHM ENGINE
2
PMA Approval
P
01
0038
SECONDLOOK DIGITAL
2
PMA Approval
P
01
0038
SECONDLOOK DIGITAL V7.2 CAD
2
PMA Approval
P
10
0005
M-VU ALGOIRITHM ENGINE
2
PMA Approval
P
97
0058
IMAGECHECKER CAD
2
PMA Approval
P
00
0041
CLEAREAD DETECT
2
PMA Approval
P
10
0007
BREAST COMPANION SOFTWARE SYSTEM
2
PMA Approval
P
10
0005
M-VU ALGORITHM ENGINE
2
PMA Approval
P
00
0041
CLEARREAD DETECT
2
PMA Approval
P
01
0038
SECONDLOOK (SL) CAD
2
PMA Approval
P
00
0041
ONGUARD
2
PMA Approval
P
01
0038
SECONDLOOK (SL) CAD
2
PMA Approval
P
01
0038
SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM
2
PMA Approval
P
00
0041
ONGUARD
2
PMA Approval
P
01
0038
SECONDLOOK
2
PMA Approval
P
03
0007
KODAK MAMMOGRAPHY CAD ENGINE
2
PMA Approval
P
97
0058
IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY
2
PMA Approval
P
98
0025
LOGICON CARIES DETECTOR
2
PMA Approval
P
00
0041
RAPIDSCREEN RS-2000D
2
PMA Approval
P
00
0041
RAPID SCREEN RS-2000, RS-2000D AND RS-DIGITAL
2
PMA Approval
P
97
0058
IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY
2
PMA Approval
P
01
0038
SECOND LOOK
2
PMA Approval
P
03
0007
MAMMOGRAPHY CAD ENGINE
2
PMA Approval
P
01
0038
SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
2
PMA Approval
P
97
0058
IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0
2
PMA Approval
P
97
0058
IMAGECHECKER D
2
PMA Approval
P
03
0007
KODAK MAMMOGRAPHY CAD ENGINE
2
PMA Approval
P
01
0038
SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
2
PMA Approval
P
01
0038
ICAD SYSTEM
2
PMA Approval
P
01
0038
ICAD SYSTEM
2
PMA Approval
P
97
0058
IMAGECHECKER M5000D AND M5000DM, (SOFTWARE VERSION 5.2)
2
PMA Approval
P
97
0058
IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)
2
PMA Approval
P
97
0058
IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)
2
PMA Approval
P
01
0038
ICAD SYSTEM
2
PMA Approval
P
01
0034
SECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY
2
PMA Approval
P
01
0038
ICAD SYSTEM
2
PMA Approval
P
01
0034
SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY
2
PMA Approval
P
97
0058
IMAGE CHECKER M1000 SYSTEM
2
PMA Approval
P
01
0034
SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY
2
PMA Approval
P
00
0041
RAPIDSCREEN RS-2000D
2
PMA Approval
P
00
0041
RAPIDSCREEN RS-2000D
2
PMA Approval
P
01
0034
SECOND LOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY
2
PMA Approval
P
01
0038
ICAD
2
PMA Approval
P
97
0058
IMAGECHECKER
2
PMA Approval
P
01
0038
ICAD
2
PMA Approval
P
01
0038
ICAD
2
PMA Approval
P
97
0058
IMAGECHECKER M1000 SYSTEM
2
PMA Approval
P
01
0034
SECOND LOOK COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY
2
PMA Approval
P
97
0058
IMAGE CHECKER M1000 SYSTEM
2
PMA Approval
P
97
0058
IMAGECHECKER M1000
2
PMA Approval
P
01
0034
SECOND LOOK (TM)
2
PMA Approval
P
01
0038
SECOND LOOK
2
PMA Approval
P
97
0058
IMAGE CHECKER (CAD) SYSTEM, M100
2
PMA Approval
P
00
0041
RAPIDSCREEN RS-2000
2
PMA Approval
P
97
0058
IMAGE CHECKER (CAD) SYSTEM, M1000
2
PMA Approval
P
97
0058
PROMINENT CALC FEATURE MARKER
2
PMA Approval
P
97
0058
IMAGE CHECKER M1000 SYSTEM
2
PMA Approval
P
97
0058
IMAGECHECKER M1000 SYSTEM
2
PMA Approval
P
97
0058
IMAGECHECKER M1000 SYSTEM
2
PMA Approval
P
97
0058
IMAGE CHECKER M1000
2
PMA Approval
P
97
0058
THE IMAGECHECKER SYSTEM
2
PMA Approval
P
97
0058
IMAGE CHECKER
2
PMA Approval
P
97
0058
IMAGECHECKER M1000 SYSTEM
2
PMA Approval
P
97
0058
IMAGECHECKER M1000 PROCESSOR WITH V1.3 RELEASE
2
PMA Approval
P
98
0025
LOGICON CARIES DETECTOR
2
PMA Approval
P
97
0058
M1000 IMAGECHECKER
2
PMA Approval
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 20 December 2024 at 11:05 pm
RA
/
subpart-b—diagnostic-devices
/
MYN
/
K213353
View Source
Aorta-CAD
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213353
510(k) Type
Traditional
Applicant
Imagen Technologies, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/20/2022
Days to Decision
347 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
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
K
24
0003
Velmeni for Dentists (V4D)
K
23
3738
Overjet Caries Assist-Pediatric
K
23
1805
qXR-LN
K
23
2384
Videa Dental Assist
K
23
0144
Denti.AI Detect
K
23
1001
DeepTek CXR Analyzer v1.0
K
23
0085
Lung-CAD
K
23
1678
Overjet Periapical Radiolucency Assist
K
22
3811
Lung-CAD
K
22
3133
VisiRad XR
K
22
1921
DTX Studio Clinic 3.0
K
22
2746
Overjet Caries Assist
K
22
0928
Overjet Calculus Assist
K
21
3353
Aorta-CAD
K
21
2519
Overjet Caries Assist
K
21
3795
Videa Caries Assist
K
21
0365
Second Opinion
K
20
1560
Auto Lung Nodule Detection
K
21
0666
Chest-CAD
P
98
0025
Logicon Caries Detection Software
P
15
0043
QVCAD System (Version 3.3)
P
16
0009
PowerLook® Tomo Detection Software
P
10
0005
M-VU ALGORITHM ENGINE
P
15
0043
QVCAD SYSTEM
P
97
0058
IMAGE CHECKER, IMAGE CHECKER LICENSE
P
98
0025
LOGICON CARIES DETECTOR
P
12
0004
PARASCRIPT (R) ACCUDETECT (R)
P
10
0005
M-VU ALGORITHM ENGINE
P
98
0025
LOGICON CARIES DETECTOR
P
10
0005
M-VU ALGORITHM ENGINE
P
97
0058
IMAGE CHECKER CAD
P
10
0005
M-VU ALGORITHM ENGINE
P
12
0004
PARASCRIPT ACCUDETECT 6.1.0
P
10
0005
M-VU ALGORITHM ENGINE
P
01
0038
SECONDLOOK DIGITAL
P
01
0038
SECONDLOOK DIGITAL V7.2 CAD
P
10
0005
M-VU ALGOIRITHM ENGINE
P
97
0058
IMAGECHECKER CAD
P
00
0041
CLEAREAD DETECT
P
10
0007
BREAST COMPANION SOFTWARE SYSTEM
P
10
0005
M-VU ALGORITHM ENGINE
P
00
0041
CLEARREAD DETECT
P
01
0038
SECONDLOOK (SL) CAD
P
00
0041
ONGUARD
P
01
0038
SECONDLOOK (SL) CAD
P
01
0038
SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM
P
00
0041
ONGUARD
P
01
0038
SECONDLOOK
P
03
0007
KODAK MAMMOGRAPHY CAD ENGINE
P
97
0058
IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY
P
98
0025
LOGICON CARIES DETECTOR
P
00
0041
RAPIDSCREEN RS-2000D
P
00
0041
RAPID SCREEN RS-2000, RS-2000D AND RS-DIGITAL
P
97
0058
IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY
P
01
0038
SECOND LOOK
P
03
0007
MAMMOGRAPHY CAD ENGINE
P
01
0038
SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
P
97
0058
IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0
P
97
0058
IMAGECHECKER D
P
03
0007
KODAK MAMMOGRAPHY CAD ENGINE
P
01
0038
SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
P
01
0038
ICAD SYSTEM
P
01
0038
ICAD SYSTEM
P
97
0058
IMAGECHECKER M5000D AND M5000DM, (SOFTWARE VERSION 5.2)
P
97
0058
IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)
P
97
0058
IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)
P
01
0038
ICAD SYSTEM
P
01
0034
SECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY
P
01
0038
ICAD SYSTEM
P
01
0034
SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY
P
97
0058
IMAGE CHECKER M1000 SYSTEM
P
01
0034
SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY
P
00
0041
RAPIDSCREEN RS-2000D
P
00
0041
RAPIDSCREEN RS-2000D
P
01
0034
SECOND LOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY
P
01
0038
ICAD
P
97
0058
IMAGECHECKER
P
01
0038
ICAD
P
01
0038
ICAD
P
97
0058
IMAGECHECKER M1000 SYSTEM
P
01
0034
SECOND LOOK COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY
P
97
0058
IMAGE CHECKER M1000 SYSTEM
P
97
0058
IMAGECHECKER M1000
P
01
0034
SECOND LOOK (TM)
P
01
0038
SECOND LOOK
P
97
0058
IMAGE CHECKER (CAD) SYSTEM, M100
P
00
0041
RAPIDSCREEN RS-2000
P
97
0058
IMAGE CHECKER (CAD) SYSTEM, M1000
P
97
0058
PROMINENT CALC FEATURE MARKER
P
97
0058
IMAGE CHECKER M1000 SYSTEM
P
97
0058
IMAGECHECKER M1000 SYSTEM
P
97
0058
IMAGECHECKER M1000 SYSTEM
P
97
0058
IMAGE CHECKER M1000
P
97
0058
THE IMAGECHECKER SYSTEM
P
97
0058
IMAGE CHECKER
P
97
0058
IMAGECHECKER M1000 SYSTEM
P
97
0058
IMAGECHECKER M1000 PROCESSOR WITH V1.3 RELEASE
P
98
0025
LOGICON CARIES DETECTOR
P
97
0058
M1000 IMAGECHECKER
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
/
MYN
/
K213353
View Source
Aorta-CAD
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213353
510(k) Type
Traditional
Applicant
Imagen Technologies, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/20/2022
Days to Decision
347 days
Submission Type
Summary