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- MiscellaneousMiscellaneous
- PCSLiver Iron Concentration Imaging Companion Diagnostic For Deferasirox2Product Code
- PDKCream For X-Ray Attenuation2Product Code
- QBSRadiological Computer Assisted Detection/Diagnosis Software For Fracture2Product Code
- QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer2Product Code
- QJUImage Acquisition And/Or Optimization Guided By Artificial Intelligence2Product Code
- QRNRadiation Therapy Marking Device2Product Code
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- LMZApplicator, Hyperthermia, Interstitial3Product Code
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- NAWMicrospheres Radionuclide3Product Code
- NCLImager, Breast, Electrical Impedance3Product Code
- OLQCross-Sectional Mammographic Xray System3Product Code
- OTEDigital Breast Tomosynthesis3Product Code
- PAAAutomated Breast Ultrasound3Product Code
- QNKOptoacoustic Imaging System3Product Code
- QUVPhase-Changing Fiducial Marker For Radiation Therapy2Product Code
- QVAFludeoxyglucose F18-Guided Radiation Therapy System2Product Code
- QVDRadiological Machine Learning Based Quantitative Imaging Software With Change Control Plan2Product Code
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- QVWGenerator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-LedNProduct Code
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- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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Imagio Breast Imaging System
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Seno Medical Instruments, Inc.
- Trade Name
- Imagio Breast Imaging System
- Generic Name
- Optoacoustic Imaging System
- Decision Date
- 1/11/2021
- Days to Decision
- 346 days
- Decision Code
- APPR
- FDA Decision
- Approval