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510(k) Data Aggregation
K Number
K192372Device Name
ASCEND Image Viewer
Manufacturer
Date Cleared
2020-02-14
(168 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Ascend Hit
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ASCEND Image Viewer is a software-only medical device intended for use by trained clinicians to display medical images. ASCEND Image Viewer provides viewing of and measurements on echocardiograms from compatible ultrasound systems that support transthoracic echocardiogram, transesophageal echocardiogram, stress echocardiogram, cath, and vascular study types.
ASCEND Image Viewer is for prescription use only.
Device Description
The ASCEND Image Viewer is a Medical Device for viewing and measuring cardiovascular echocardiograms in DICOM format.
The software has features for displaying and measuring cardiovascular images acquired from echocardiograms. Images supported include:
- . 2D
- Color Doppler
- M-mode
- . Spectral Doppler (Pulsed Wave and Continuous Wave)
The ASCEND Image Viewer provides Cine play review and control.
Standard Review supported study types include:
- TTE
- TEE
- Cath
- . Stress Echo
- Vascular
Supported Measurements include:
- Linear
- . Volume (method of discs)
- Velocity time integral
- Pressure half-time
- . Area
- Time
- Velocity
- Angle (measurement of two lines with a common vertex drawn on the image) .
The user can make measurements which persist for later use within the ASCEND Image Viewer.
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