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510(k) Data Aggregation
K Number
K072515Device Name
EMBRACE GEL
Manufacturer
ORISON CORPORATION
Date Cleared
2007-09-20
(13 days)
Product Code
MUI
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
ORISON CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Embrace Gel is intended for use as an ultrasound coupling media for use with the Embrace™ 3D Ultrasound Tomography System K070477.
Device Description
Embrace™ Gel Pad is en expandable polymer used to provide a coupling medium between breast tissue and the Embrace™ 3D Ultrasound Tomography System K070477. The gel is prepared just prior to scanning by placing the gel pad in the dome and adding hydrating fluid. The gel pad expands and fills the voids between the probe and breast tissue. After the ultrasound scan is completed, the gel is removed from the dome in one piece.
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K Number
K070477Device Name
ORISON EMBRACE SYSTEM
Manufacturer
ORISON CORPORATION
Date Cleared
2007-03-09
(17 days)
Product Code
IYO, ITX
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
ORISON CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Orison Embrace is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of the patients breast when used with an automatic scanning linear array transducer.
Device Description
The Embrace™ 3D Ultrasound Tomography System is an easy to use diagnostic ultrasound system to be used as an adjunct to mammography for imaging a patient's breast. Ultrasound images are acquired using a general purpose ultrasound system capable of B-mode imaging in conjunction with an automatic scanning concave transducer. The acquired images are reconstructed using 3-D visualization software at a separate clinical review workstation.
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