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
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
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
P
20
0040
SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly
APPR
PMA Approval
P
11
0006
SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)
APPR
PMA Approval
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
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 13 December 2024 at 11:05 pm
RA
/
RA-misc
/
PAA
/
P200040
View Source
SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Delphinus Medical Technologies
Trade Name
SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly
Generic Name
Automated breast ultrasound
Decision Date
10/6/2021
Days to Decision
398 days
Decision Code
APPR
FDA Decision
Approval
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
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
P
20
0040
SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly
P
11
0006
SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)
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
/
PAA
/
P200040
View Source
SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Delphinus Medical Technologies
Trade Name
SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly
Generic Name
Automated breast ultrasound
Decision Date
10/6/2021
Days to Decision
398 days
Decision Code
APPR
FDA Decision
Approval