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510(k) Data Aggregation
K Number
K963807Device Name
TOMTEC ECHO-SCAN
Manufacturer
TOMTEC IMAGING SYSTEMS, INC.
Date Cleared
1996-12-18
(86 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
TOMTEC IMAGING SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TomTec Echo-Scan is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. The Echo-Scan acquires sets of 2D images and stores them digitally in the TomTec standard 3D image file format for subsequent 3D tomographic reconstruction and surface rendering with either the Echo-Scan or Echo-View. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology, The TomTec Freehand Scanning Device is intended for acquiring a sequence of conventional 2D ultrasound images with transducer position recorded for each image acquired. The resulting image data set is intended for storage in the TomTec standard 3D image file format for subsequent 3D tomographic image reconstruction.
Device Description
The TomTec Echo-Scan is a high performance computer system based on Intel motherboard and Microsoft DOS/Windows standards. It incorporates a proprietary image digitizer circuit board and proprietary software for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets. The TomTec Freehand Scanning Device records ultrasound transducer spatial position in six degrees of freedom during use. 2D ultrasound images are acquired sequentially in a series of steps as the ultrasound transducer is swept across the patient scan site.
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