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510(k) Data Aggregation
K Number
K110447Device Name
ECHOINSIGHT
Manufacturer
Date Cleared
2011-05-27
(100 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ULTRASOUND MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended for use by or on the order of a qualified physician for analysis of ultrasound imaging of the human heart. Cardiac (adult and pediatric) applications using B-mode (including harmonic) imaging are supported. The system provides image data analysis applications that supply information on cardiac structure and motion.
Device Description
The Echolnsight™ software system enables the production and visualization of 2D tissue motion measurements (including tissue velocities, strain rates) and cardiac structural measurement information derived from tracking speckle in tissue regions visualized in any Bmode (including harmonic) imagery loops as captured by most commercial ultrasound systems.
The Echolnsight™ software system has been designed to ingest and process ultrasound imagery stored in files with content organized and encoded in conformance to the following the following standards:
- NEMA PS3 (3.3, 3.5, 3.6, 3.10): Digital Imaging and Communications in Medicine . (DICOM), 2008.
- ISO/IEC 10918-1:1994-02: Information technology Digital compression and coding of . continuous-tone still images – Requirements and guidelines (JPEG standard), 1994.
- ISO/IEC 15444-1:2004: Information technology JPEG 2000 image coding system: . Core coding system, 2004.
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K Number
K100363Device Name
ULTRA DCI MODEL 5000
Manufacturer
Date Cleared
2010-05-21
(98 days)
Product Code
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
ULTRASOUND MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ultra DCI 5000 System is intended for use by, or on the order of, a qualified physician for ultrasound imaging of the human heart. The cardiac (adult and pediatric) application using Bmode imaging is supported.
Device Description
The Ultra DC1 Model 5000 is a general purpose, mobile, software-controlled, diagnostic ultrasound system designed to provide the user with the ability to collect standard 2D brightness mode (B-mode) echocardiographic views of the heart, visualize these views and store the collected data for later visualization. The device includes a 4-lead electrocardiograpic (ECG) module and patient connections to collect and display a single ECG trace (PQRST wave) along with the B-mode imagery.
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