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Miscellaneous
Miscellaneous
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
Product Code
QDQ
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
2
Product Code
K
24
1747
Saige-Dx
2
Cleared 510(K)
K
24
0417
ProFound Detection (V4.0)
2
Cleared 510(K)
K
24
2652
Lunit INSIGHT DBT v1.1
2
Cleared 510(K)
K
24
0697
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
2
Cleared 510(K)
K
24
0301
MammoScreen® (3)
2
Cleared 510(K)
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
Cleared 510(K)
K
21
2783
ProstatID
2
Cleared 510(K)
Show All 23 Submissions
QJU
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
2
Product Code
QRN
Radiation Therapy Marking Device
2
Product Code
KTA
Medium, Contrast, Radiologic
U
Product Code
LMZ
Applicator, Hyperthermia, Interstitial
3
Product Code
LNB
Applicator, Hyperthermia, Deep Heating, Ultrasound
3
Product Code
LNC
Applicator, Hyperthermia, Superficial, Rf/Microwave
3
Product Code
LOC
System, Rf/Microwave Hyperthermia, Cancer Treatment
3
Product Code
LSY
Ultrasound, Hyperthermia, Cancer Treatment
3
Product Code
MJS
Contrast Media, Ultrasound
3
Product Code
MOT
Irradiator, Blood To Prevent Graft Versus Host Disease
U
Product Code
NAN
Tester, Acoustic, Bone Quality
3
Product Code
NAW
Microspheres Radionuclide
3
Product Code
NCL
Imager, Breast, Electrical Impedance
3
Product Code
OLQ
Cross-Sectional Mammographic Xray System
3
Product Code
OTE
Digital Breast Tomosynthesis
3
Product Code
PAA
Automated Breast Ultrasound
3
Product Code
QNK
Optoacoustic Imaging System
3
Product Code
QUV
Phase-Changing Fiducial Marker For Radiation Therapy
2
Product Code
QVA
Fludeoxyglucose F18-Guided Radiation Therapy System
2
Product Code
QVD
Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
2
Product Code
QXR
Vaginal Hydrogel Packing System
2
Product Code
QVW
Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led
N
Product Code
QZL
Post-Ablation Tissue Response Prediction Software
2
Product Code
QWO
Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
2
Product Code
SAO
Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
2
Product Code
Submissions with No Product Code
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
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
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Review Panel
Last synced on 30 November 2024 at 11:09 am
RA
/
RA-misc
/
QDQ
/
K240301
View Source
MammoScreen® (3)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240301
510(k) Type
Traditional
Applicant
Therapixel
Country
France
FDA Decision
Substantially Equivalent
Decision Date
8/1/2024
Days to Decision
182 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
24
1747
Saige-Dx
K
24
0417
ProFound Detection (V4.0)
K
24
2652
Lunit INSIGHT DBT v1.1
K
24
0697
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
K
24
0301
MammoScreen® (3)
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
Show All 23 Submissions
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
/
K240301
View Source
MammoScreen® (3)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240301
510(k) Type
Traditional
Applicant
Therapixel
Country
France
FDA Decision
Substantially Equivalent
Decision Date
8/1/2024
Days to Decision
182 days
Submission Type
Summary