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PCS
Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
2
Product Code
PDK
Cream For X-Ray Attenuation
2
Product Code
QBS
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
2
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QDQ
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
2
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K
23
1470
Lunit INSIGHT DBT
2
Cleared 510(K)
K
23
0096
Genius AI Detection 2.0 with CC-MLO Correlation
2
Cleared 510(K)
K
22
1449
Genius AI Detection 2.0
2
Cleared 510(K)
K
22
1347
Transpara 1.7.2
2
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K
21
2783
ProstatID
2
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K
22
0105
Saige-Dx
2
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K
21
0670
BU-CAD
2
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K
21
1541
MammoScreen 2.0
2
Cleared 510(K)
K
21
1678
Lunit INSIGHT MMG
2
Cleared 510(K)
K
21
0404
Transpara 1.7.0
2
Cleared 510(K)
K
20
3822
ProFound AI Software V3.0
2
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K
20
1019
Genius AI Detection
2
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K
19
2854
MammoScreen
2
Cleared 510(K)
K
19
3229
Transpara
2
Cleared 510(K)
K
19
2287
Transpara
2
Cleared 510(K)
K
19
1994
ProFound AI Software V2.1
2
Cleared 510(K)
K
18
2373
PowerLook Tomo Detection V2 Software
2
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K
18
1704
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2
Cleared 510(K)
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Image Acquisition And/Or Optimization Guided By Artificial Intelligence
2
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Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led
N
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Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
2
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Last synced on 16 August 2024 at 11:05 pm
RA
/
RA-misc
/
QDQ
/
K181704
View Source
Transpara
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181704
510(k) Type
Traditional
Applicant
ScreenPoint Medical BV
Country
Netherlands
FDA Decision
Substantially Equivalent
Decision Date
11/21/2018
Days to Decision
147 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
PCS
Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
PDK
Cream For X-Ray Attenuation
QBS
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
QDQ
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
K
23
1470
Lunit INSIGHT DBT
K
23
0096
Genius AI Detection 2.0 with CC-MLO Correlation
K
22
1449
Genius AI Detection 2.0
K
22
1347
Transpara 1.7.2
K
21
2783
ProstatID
K
22
0105
Saige-Dx
K
21
0670
BU-CAD
K
21
1541
MammoScreen 2.0
K
21
1678
Lunit INSIGHT MMG
K
21
0404
Transpara 1.7.0
K
20
3822
ProFound AI Software V3.0
K
20
1019
Genius AI Detection
K
19
2854
MammoScreen
K
19
3229
Transpara
K
19
2287
Transpara
K
19
1994
ProFound AI Software V2.1
K
18
2373
PowerLook Tomo Detection V2 Software
K
18
1704
Transpara
QJU
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
QRN
Radiation Therapy Marking Device
KTA
Medium, Contrast, Radiologic
LMZ
Applicator, Hyperthermia, Interstitial
LNB
Applicator, Hyperthermia, Deep Heating, Ultrasound
LNC
Applicator, Hyperthermia, Superficial, Rf/Microwave
LOC
System, Rf/Microwave Hyperthermia, Cancer Treatment
LSY
Ultrasound, Hyperthermia, Cancer Treatment
MJS
Contrast Media, Ultrasound
MOT
Irradiator, Blood To Prevent Graft Versus Host Disease
NAN
Tester, Acoustic, Bone Quality
NAW
Microspheres Radionuclide
NCL
Imager, Breast, Electrical Impedance
OLQ
Cross-Sectional Mammographic Xray System
OTE
Digital Breast Tomosynthesis
PAA
Automated Breast Ultrasound
QNK
Optoacoustic Imaging System
QUV
Phase-Changing Fiducial Marker For Radiation Therapy
QVA
Fludeoxyglucose F18-Guided Radiation Therapy System
QVD
Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
QXR
Vaginal Hydrogel Packing System
QVW
Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led
QZL
Post-Ablation Tissue Response Prediction Software
QWO
Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
SAO
Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
Submissions with No Product Code
Subpart B—Diagnostic Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous Devices
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
RA
/
RA-misc
/
QDQ
/
K181704
View Source
Transpara
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181704
510(k) Type
Traditional
Applicant
ScreenPoint Medical BV
Country
Netherlands
FDA Decision
Substantially Equivalent
Decision Date
11/21/2018
Days to Decision
147 days
Submission Type
Summary