ASCEND InView

GUDID 00860006348014

ASCEND InView v9.5 is a software-only medical device intended for use by trained clinicians to display medical images. The 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 InView v9.5 is for use by prescription only. The 9.5 update is equivalent to the prior release in functionality with updates to the user experience and playback performance for a better experience to the end user.

Ascend Cardiovascular LLC

Radiology DICOM image processing application software
Primary Device ID00860006348014
NIH Device Record Key2614da58-4395-46ce-b38f-6c869120a2c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameASCEND InView
Version Model Number9.5
Company DUNS092700132
Company NameAscend Cardiovascular LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8444132610
Emailinformation@ascendcv.com
Phone8444132610
Emailinformation@ascendcv.com
Phone8444132610
Emailinformation@ascendcv.com
Phone8444132610
Emailinformation@ascendcv.com
Phone8444132610
Emailinformation@ascendcv.com
Phone8444132610
Emailinformation@ascendcv.com
Phone8444132610
Emailinformation@ascendcv.com
Phone8444132610
Emailinformation@ascendcv.com
Phone8444132610
Emailinformation@ascendcv.com
Phone8444132610
Emailinformation@ascendcv.com
Phone8444132610
Emailinformation@ascendcv.com
Phone8444132610
Emailinformation@ascendcv.com
Phone8444132610
Emailinformation@ascendcv.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860006348014 [Primary]
GS100860006348021 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-30
Device Publish Date2024-10-22

On-Brand Devices [ASCEND InView]

00860006348021InView automatically categorizes adult Transthoracic Echo (TTE) images by view/modality, reorgan
00860006348014ASCEND InView v9.5 is a software-only medical device intended for use by trained clinicians to d

Trademark Results [ASCEND InView]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ASCEND INVIEW
ASCEND INVIEW
88710358 not registered Live/Pending
Ascend Hit LLC
2019-11-29

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