ASCEND InView
GUDID 00860006348021
InView automatically categorizes adult Transthoracic Echo (TTE) images by view/modality, reorganizes images according to relevant categorical attributes, and syncs all related views for current and prior studies.
Ascend Cardiovascular LLC
Radiology DICOM image processing application software| Primary Device ID | 00860006348021 |
| NIH Device Record Key | e06702c7-47e7-4f97-93c0-4511f67b2016 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASCEND InView |
| Version Model Number | 9.0 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860006348021 [Primary] |
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 | 2023-10-04 |
| Device Publish Date | 2023-09-26 |
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 |
Trademark Results [ASCEND InView]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ASCEND INVIEW 88710358 not registered Live/Pending |
Ascend Hit LLC 2019-11-29 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.