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 ID: 00860006348014
• NIH Device Record Key: 2614da58-4395-46ce-b38f-6c869120a2c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASCEND InView
• Version Model Number: 9.5
• Company DUNS: 092700132
• Company Name: Ascend Cardiovascular LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8444132610
• Email: information@ascendcv.com
• Phone: 8444132610
• Email: information@ascendcv.com
• Phone: 8444132610
• Email: information@ascendcv.com
• Phone: 8444132610
• Email: information@ascendcv.com
• Phone: 8444132610
• Email: information@ascendcv.com
• Phone: 8444132610
• Email: information@ascendcv.com
• Phone: 8444132610
• Email: information@ascendcv.com
• Phone: 8444132610
• Email: information@ascendcv.com
• Phone: 8444132610
• Email: information@ascendcv.com
• Phone: 8444132610
• Email: information@ascendcv.com
• Phone: 8444132610
• Email: information@ascendcv.com
• Phone: 8444132610
• Email: information@ascendcv.com
• Phone: 8444132610
• Email: information@ascendcv.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006348014 [Primary]
GS1	00860006348021 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192372

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-30
• Device Publish Date: 2024-10-22

On-Brand Devices [ASCEND InView]

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