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510(k) Data Aggregation
K Number
K002856Device Name
AT3C70 TRANSDUCER
Manufacturer
SONORA MEDICAL SYSTEMS
Date Cleared
2001-04-02
(201 days)
Product Code
ITX
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
SONORA MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994385Device Name
BABY FACE
Manufacturer
SONORA MEDICAL SYSTEMS
Date Cleared
2000-03-16
(79 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
SONORA MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to be used by or under the direction of a physician and in conjunction with standard ultrasound for 3D clinical imaging in fetal applications
Device Description
Adds 3D imaging capability to commercial 2D ultrasound imaging systems. Hardware includes a Cyrix 266 MHz processor, Frame Grabber (VHS/S-VHS Input), Video out, and a Handheld controller. Software features include Volume data acquisition w/frame grabbing of video data b/w while using a Gyroscopic sensor system, Conditioning & transformation of the acquired data into a Cartesian volume, Surface rendering, and Segmentation of structures from 3D data.
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