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510(k) Data Aggregation
K Number
K980308Device Name
ECHOTECH 3D FREESCAN
Manufacturer
ECHOTECH 3D IMAGING SYSTEMS GMBH
Date Cleared
1998-05-06
(99 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
ECHOTECH 3D IMAGING SYSTEMS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ECHOTECH 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, obstetrics and gynecology.
Device Description
The EchoTech 3D FreeScan is a high performance computer system based on Intel motherboard and Microsoft DOS/Windows standards. It incorporates a commercially available image digitizer circuit board and proprietary software for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets. The device is an add-on accessory for any existing diagnostic imaging ultrasound system.
The device records ultrasound transducer spatial position in six degrees of freedom during use. Coordinate tracking is achieved with a miniature magnetic field sensor within a transmitted pulsed magnetic field. This is done by attaching a plastic holding plate to the probe of the host ultrasound system, to which the receiver of an electromagnetic sensor device is attached.
2D ultrasound images are acquired sequentially in a series of steps as the ultrasound transducer is swept across the patient scan site. The resulting set of digitized 2D images is then converted into a 3D data volume.
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