Home GUDID 00852698007119
Terason
Primary DI 00852698007119
Brand Terason
Company TERATECH CORPORATION
Model uSmart3200T
Device description The Terason uSmart3200T is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intraoperative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac), Musculoskeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), and Peripheral Vascular.
Published 2018-04-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name ITX Transducer, Ultrasonic, Diagnostic IYN System, Imaging, Pulsed Doppler, Ultrasonic IYO System, Imaging, Pulsed Echo, Ultrasonic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ITX Transducer, Ultrasonic, Diagnostic Radiology 2 IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology 2 IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00852698007119 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00852698007119 00852698007119 852698007119 0852698007119
GMDN Terms# Term, Definition table Term Definition Hand-held ultrasound imaging system, body-surface A battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum.
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