Us2.v2
Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyze and make measurements on images in order to provide automated estimation of several cardiac…
Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyze and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters, including left/ right atrial and ventricular linear dimensions, volumes, systolic function and diastolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision-making. Us2.v2 is indicated for use in adult patients. Please note the following limitations: • Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. • Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. • If no gender is present, female referenced guideline values will be used for conclusions. • If Body Surface Area (BSA) is not present, indexed values cannot be provided. • During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software.
Who Else Makes It
Concentrated in Beijing (4), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
| Wuhan United Imaging Healthcare Co., Ltd. | Wuhan | Hubei | Manufacturer | 4 |
| Keya Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Eko.ai PTE. Ltd., Singapore |
|---|---|
| FDA product code | QIH |
| Device type | Automated Radiological Image Processing Software |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Manufacturer |
| Record published | 2024-04-22 |
| Record revised | 2026-05-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imbio RV/LV | Imbio, LLC | 5 |
| VEA Align | EOS imaging | 4 |
| Qlab Advanced Quantification Software | Philips Ultrasound LLC | 3 |
| uOmnispace | Shanghai United Imaging Healthcare Co., Ltd. | 3 |
| Scenium | Siemens Medical Solutions USA, Inc. | 3 |
| syngo.MI General | Siemens Medical Solutions USA, Inc. | 3 |
| Neosoma Dashboard | Neosoma, Inc. | 3 |
| BriefCase-Quantification | Aidoc Medical Ltd. | 3 |
| OrthoNext™ Platform System Software | Orthofix SRL | 3 |
| MI View&GO | Siemens Medical Solutions USA, Inc. | 3 |
| FEops | Feops NV | 3 |
| AI-Rad Companion Brain MR | Siemens Healthcare Limited | 3 |
Showing 12 of 147. All products under Automated Radiological Image Processing Software
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.