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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

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