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
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
K
23
4009
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
2
Cleared 510(K)
K
23
3457
RUS
2
Cleared 510(K)
K
24
1329
SubtleSYNTH (1.x)
2
Cleared 510(K)
K
24
0736
SMART Bun-Yo-Matic X-Ray
2
Cleared 510(K)
K
24
0582
VEA Align; spineEOS
2
Cleared 510(K)
K
23
3196
Medihub Prostate
2
Cleared 510(K)
K
24
0642
SMART Bun-Yo-Matic CT
2
Cleared 510(K)
K
24
1083
SIS System
2
Cleared 510(K)
K
23
3925
Relu Creator
2
Cleared 510(K)
K
24
1038
Cardiac CT Function Software Application
2
Cleared 510(K)
K
23
4042
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
2
Cleared 510(K)
K
24
0769
LVivo IQS
2
Cleared 510(K)
K
23
3209
uOmnispace.CT
2
Cleared 510(K)
K
24
1112
BriefCase-Quantification
2
Cleared 510(K)
K
23
2331
InVision Precision LVEF (LVEF)
2
Cleared 510(K)
K
23
3186
uOmnispace.MR
2
Cleared 510(K)
K
24
0172
Preview Shoulder
2
Cleared 510(K)
K
23
3676
Us2.v2
2
Cleared 510(K)
K
23
3211
AVIEW CAC
2
Cleared 510(K)
K
23
3030
BoneMRI
2
Cleared 510(K)
K
23
1690
iCAS-LV
2
Cleared 510(K)
K
23
1683
inHEART Models
2
Cleared 510(K)
K
23
2613
CT Cardiomegaly
2
Cleared 510(K)
K
23
3590
Overjet Charting Assist
2
Cleared 510(K)
K
23
2363
Viz HDS, Viz Volume Plus, Viz ICH+
2
Cleared 510(K)
K
23
2698
NemoScan
2
Cleared 510(K)
K
23
3512
Rapid (6.0)
2
Cleared 510(K)
K
23
1324
DASI Dimensions (V1.0)
2
Cleared 510(K)
K
23
1917
VEA Align
2
Cleared 510(K)
K
23
1130
TumorSight Viz
2
Cleared 510(K)
K
23
1929
iQ-solutions
2
Cleared 510(K)
K
23
2231
QP-Brain®
2
Cleared 510(K)
K
23
2096
Transpara Density 1.0.0
2
Cleared 510(K)
K
23
3568
Ceevra Reveal 3+
2
Cleared 510(K)
K
23
2440
Adravision Perio
2
Cleared 510(K)
K
23
2856
Syngo Carbon Clinicals
2
Cleared 510(K)
K
23
2000
syngo.via MI Workflows; Scenium; syngo MBF
2
Cleared 510(K)
K
23
2501
AI Platform (AIP001)
2
Cleared 510(K)
K
23
2841
Axial3D Insight
2
Cleared 510(K)
K
23
2257
Clarius Bladder AI
2
Cleared 510(K)
K
23
2083
BriefCase-Quantification
2
Cleared 510(K)
K
23
0534
BriefCase-Quantification
2
Cleared 510(K)
K
23
1955
aprevo® Digital Segmentation
2
Cleared 510(K)
K
23
2305
AI-Rad Companion Brain MR
2
Cleared 510(K)
K
23
0209
Sonix Health
2
Cleared 510(K)
K
23
2367
cmAngio® V1.0
2
Cleared 510(K)
K
23
1398
VUNO Med-DeepBrain
2
Cleared 510(K)
K
23
0045
HipCheck
2
Cleared 510(K)
K
23
1149
qXR-CTR
2
Cleared 510(K)
K
22
3621
DeepXray
2
Cleared 510(K)
K
23
0913
ANDI
2
Cleared 510(K)
K
23
0150
OptimMRI
2
Cleared 510(K)
K
23
0039
uOmnispace
2
Cleared 510(K)
K
22
3106
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)
2
Cleared 510(K)
K
23
1668
Spine CAMP™ (1.1)
2
Cleared 510(K)
K
22
2745
Axial3D Insight
2
Cleared 510(K)
K
23
0497
Bladder AI (AIBV01)
2
Cleared 510(K)
K
22
3646
IB Lab LAMA
2
Cleared 510(K)
K
22
3556
DeepCatch
2
Cleared 510(K)
K
22
3855
FEops HEARTguideTM, FEops HEARTguideTM ALPACA
2
Cleared 510(K)
K
23
0977
SIS System
2
Cleared 510(K)
K
22
2676
Ceevra Reveal 3
2
Cleared 510(K)
K
22
3501
ViewFinder Software Version 1.1
2
Cleared 510(K)
K
21
3986
CerebralGo Plus
2
Cleared 510(K)
K
21
3272
Formus Hip
2
Cleared 510(K)
K
22
2174
RadioLens v1.0
2
Cleared 510(K)
K
22
2036
MPXA-2000
2
Cleared 510(K)
K
23
0197
BoneMRI v1.6
2
Cleared 510(K)
K
22
3296
Videa Perio Assist
2
Cleared 510(K)
K
22
3396
Rapid RV/LV
2
Cleared 510(K)
K
22
2970
LVivo IQS
2
Cleared 510(K)
K
22
2406
Clarius AI
2
Cleared 510(K)
K
21
4036
AVIEW
2
Cleared 510(K)
K
22
3268
BrainInsight
2
Cleared 510(K)
K
22
2275
Saige-Density
2
Cleared 510(K)
K
22
3032
SIS System (Version 5.6.0)
2
Cleared 510(K)
K
22
1762
BoneMRI v1.4
2
Cleared 510(K)
K
22
2428
Syngo Dynamics (Version VA40F)
2
Cleared 510(K)
K
22
1632
Spine CAMP™
2
Cleared 510(K)
K
21
1611
QIR Suite
2
Cleared 510(K)
K
22
1738
NS-HGlio
2
Cleared 510(K)
K
22
1100
Viz RV/LV
2
Cleared 510(K)
K
22
2172
MI View&GO
2
Cleared 510(K)
K
21
3645
ClearPoint Maestro Brain Model
2
Cleared 510(K)
K
22
1432
Customize
2
Cleared 510(K)
K
21
3998
cvi42 Auto Imaging Software Application
2
Cleared 510(K)
K
22
0940
EchoPAC Software Only, EchoPAC Plug-in
2
Cleared 510(K)
K
22
0956
Libby Echo:Prio
2
Cleared 510(K)
K
22
0815
BrainInsight
2
Cleared 510(K)
K
22
0497
CoLumbo
2
Cleared 510(K)
K
21
3706
AI-Rad Companion Brain MR
2
Cleared 510(K)
K
21
2624
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
2
Cleared 510(K)
K
21
3779
Customize
2
Cleared 510(K)
K
20
3744
Arterys MICA
2
Cleared 510(K)
K
21
2012
Follicle Clarity
2
Cleared 510(K)
K
21
0747
Caption Interpretation Automated Ejection Fraction Software
2
Cleared 510(K)
K
21
3544
TOMTEC-ARENA
2
Cleared 510(K)
K
20
2404
BoneMRI
2
Cleared 510(K)
K
21
2690
qXR-BT
2
Cleared 510(K)
K
21
3275
EchoGo Core (2.0)
2
Cleared 510(K)
K
21
2466
LVivo Seamless
2
Cleared 510(K)
K
21
0831
OnQ Neuro
2
Cleared 510(K)
K
21
1161
Critical Care Suite with Endotracheal Tube Positing AI algorithm
2
Cleared 510(K)
K
20
3785
ClariSIGMAM
2
Cleared 510(K)
K
20
3555
AmCAD-UT
2
Cleared 510(K)
K
21
1431
breastscape v1.0
2
Cleared 510(K)
K
21
1222
qER-Quant
2
Cleared 510(K)
K
21
0791
Us2.v1
2
Cleared 510(K)
K
21
0719
Change Healthcare Anatomical AI
2
Cleared 510(K)
K
21
1506
PowerLook Density Assessment V4.0
2
Cleared 510(K)
K
21
1459
syngo.via MI WorkFlows, Scenium, syngo MBF
2
Cleared 510(K)
K
20
3502
MEDO-Thyroid
2
Cleared 510(K)
K
21
0556
Preview Shoulder
2
Cleared 510(K)
K
20
3256
Imbio RV/LV Software
2
Cleared 510(K)
K
21
0053
LVivo Software Application
2
Cleared 510(K)
K
20
1411
Visage Breast Density
2
Cleared 510(K)
K
20
1195
syngo.via MI Workflows, syngo MBF
2
Cleared 510(K)
K
20
2013
WRDensity by Whiterabbit.ai
2
Cleared 510(K)
K
20
2546
LVivo Seamless
2
Cleared 510(K)
K
19
3283
AI-Rad Companion Prostate MR
2
Cleared 510(K)
K
20
0621
Caption Interpretation Automated Ejection Fraction Software
2
Cleared 510(K)
K
19
2969
Ezra Plexo Software
2
Cleared 510(K)
K
20
0232
LVivo Software Application
2
Cleared 510(K)
K
20
0356
MEDO ARIA
2
Cleared 510(K)
K
20
0974
QLAB Advanced Quantification Software
2
Cleared 510(K)
K
19
2601
uWS-MR
2
Cleared 510(K)
K
19
2437
Arterys MICA
2
Cleared 510(K)
K
19
1647
QLAB Advanced Quantification Software
2
Cleared 510(K)
K
19
1171
EchoGo Core
2
Cleared 510(K)
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 16 August 2024 at 11:05 pm
RA
/
subpart-b—diagnostic-devices
/
QIH
/
K193283
View Source
AI-Rad Companion Prostate MR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193283
510(k) Type
Traditional
Applicant
Siemens Medical Solutions USA Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/30/2020
Days to Decision
246 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
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
K
23
4009
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
K
23
3457
RUS
K
24
1329
SubtleSYNTH (1.x)
K
24
0736
SMART Bun-Yo-Matic X-Ray
K
24
0582
VEA Align; spineEOS
K
23
3196
Medihub Prostate
K
24
0642
SMART Bun-Yo-Matic CT
K
24
1083
SIS System
K
23
3925
Relu Creator
K
24
1038
Cardiac CT Function Software Application
K
23
4042
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
K
24
0769
LVivo IQS
K
23
3209
uOmnispace.CT
K
24
1112
BriefCase-Quantification
K
23
2331
InVision Precision LVEF (LVEF)
K
23
3186
uOmnispace.MR
K
24
0172
Preview Shoulder
K
23
3676
Us2.v2
K
23
3211
AVIEW CAC
K
23
3030
BoneMRI
K
23
1690
iCAS-LV
K
23
1683
inHEART Models
K
23
2613
CT Cardiomegaly
K
23
3590
Overjet Charting Assist
K
23
2363
Viz HDS, Viz Volume Plus, Viz ICH+
K
23
2698
NemoScan
K
23
3512
Rapid (6.0)
K
23
1324
DASI Dimensions (V1.0)
K
23
1917
VEA Align
K
23
1130
TumorSight Viz
K
23
1929
iQ-solutions
K
23
2231
QP-Brain®
K
23
2096
Transpara Density 1.0.0
K
23
3568
Ceevra Reveal 3+
K
23
2440
Adravision Perio
K
23
2856
Syngo Carbon Clinicals
K
23
2000
syngo.via MI Workflows; Scenium; syngo MBF
K
23
2501
AI Platform (AIP001)
K
23
2841
Axial3D Insight
K
23
2257
Clarius Bladder AI
K
23
2083
BriefCase-Quantification
K
23
0534
BriefCase-Quantification
K
23
1955
aprevo® Digital Segmentation
K
23
2305
AI-Rad Companion Brain MR
K
23
0209
Sonix Health
K
23
2367
cmAngio® V1.0
K
23
1398
VUNO Med-DeepBrain
K
23
0045
HipCheck
K
23
1149
qXR-CTR
K
22
3621
DeepXray
K
23
0913
ANDI
K
23
0150
OptimMRI
K
23
0039
uOmnispace
K
22
3106
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)
K
23
1668
Spine CAMP™ (1.1)
K
22
2745
Axial3D Insight
K
23
0497
Bladder AI (AIBV01)
K
22
3646
IB Lab LAMA
K
22
3556
DeepCatch
K
22
3855
FEops HEARTguideTM, FEops HEARTguideTM ALPACA
K
23
0977
SIS System
K
22
2676
Ceevra Reveal 3
K
22
3501
ViewFinder Software Version 1.1
K
21
3986
CerebralGo Plus
K
21
3272
Formus Hip
K
22
2174
RadioLens v1.0
K
22
2036
MPXA-2000
K
23
0197
BoneMRI v1.6
K
22
3296
Videa Perio Assist
K
22
3396
Rapid RV/LV
K
22
2970
LVivo IQS
K
22
2406
Clarius AI
K
21
4036
AVIEW
K
22
3268
BrainInsight
K
22
2275
Saige-Density
K
22
3032
SIS System (Version 5.6.0)
K
22
1762
BoneMRI v1.4
K
22
2428
Syngo Dynamics (Version VA40F)
K
22
1632
Spine CAMP™
K
21
1611
QIR Suite
K
22
1738
NS-HGlio
K
22
1100
Viz RV/LV
K
22
2172
MI View&GO
K
21
3645
ClearPoint Maestro Brain Model
K
22
1432
Customize
K
21
3998
cvi42 Auto Imaging Software Application
K
22
0940
EchoPAC Software Only, EchoPAC Plug-in
K
22
0956
Libby Echo:Prio
K
22
0815
BrainInsight
K
22
0497
CoLumbo
K
21
3706
AI-Rad Companion Brain MR
K
21
2624
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
K
21
3779
Customize
K
20
3744
Arterys MICA
K
21
2012
Follicle Clarity
K
21
0747
Caption Interpretation Automated Ejection Fraction Software
K
21
3544
TOMTEC-ARENA
K
20
2404
BoneMRI
K
21
2690
qXR-BT
K
21
3275
EchoGo Core (2.0)
K
21
2466
LVivo Seamless
K
21
0831
OnQ Neuro
K
21
1161
Critical Care Suite with Endotracheal Tube Positing AI algorithm
K
20
3785
ClariSIGMAM
K
20
3555
AmCAD-UT
K
21
1431
breastscape v1.0
K
21
1222
qER-Quant
K
21
0791
Us2.v1
K
21
0719
Change Healthcare Anatomical AI
K
21
1506
PowerLook Density Assessment V4.0
K
21
1459
syngo.via MI WorkFlows, Scenium, syngo MBF
K
20
3502
MEDO-Thyroid
K
21
0556
Preview Shoulder
K
20
3256
Imbio RV/LV Software
K
21
0053
LVivo Software Application
K
20
1411
Visage Breast Density
K
20
1195
syngo.via MI Workflows, syngo MBF
K
20
2013
WRDensity by Whiterabbit.ai
K
20
2546
LVivo Seamless
K
19
3283
AI-Rad Companion Prostate MR
K
20
0621
Caption Interpretation Automated Ejection Fraction Software
K
19
2969
Ezra Plexo Software
K
20
0232
LVivo Software Application
K
20
0356
MEDO ARIA
K
20
0974
QLAB Advanced Quantification Software
K
19
2601
uWS-MR
K
19
2437
Arterys MICA
K
19
1647
QLAB Advanced Quantification Software
K
19
1171
EchoGo Core
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
/
QIH
/
K193283
View Source
AI-Rad Companion Prostate MR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193283
510(k) Type
Traditional
Applicant
Siemens Medical Solutions USA Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/30/2020
Days to Decision
246 days
Submission Type
Summary