Lvivo Seamless
LVivo Seamless processes echocardiography examinations offline on a server in a healthcare environment. It accepts ultrasound examinations in DICOM format and automatically selects suitable…
LVivo Seamless processes echocardiography examinations offline on a server in a healthcare environment. It accepts ultrasound examinations in DICOM format and automatically selects suitable clips for evaluation of left ventricular ejection fraction. The selected clips are then processed by the LVivo EF module.
After automatic evaluation, results are sent to the picture archiving and communication system for review by a healthcare professional. The software supports biplane evaluation using two-chamber and four-chamber views, with automatic selection of end-diastolic and end-systolic frames.
Evaluation Workflow
The application performs volume calculations using Simpson’s method of discs and presents ejection fraction results. Its Seamless workflow uses automatic clip processing without manual adjustment of the ventricular contours within the application.
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 | Dia Imaging Analysis, Ltd., Israel |
|---|---|
| FDA product code | QIH |
| Device type | Automated Radiological Image Processing Software |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| 510(k) | K202546 |
| Record published | 2022-08-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Lvivo_Seamless | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243862 | 2025-03-17 |
| K243331 | 2025-03-06 |
| K243235 | 2025-03-03 |
| K240553 | 2024-10-04 |
| K240769 | 2024-05-24 |
| K222970 | 2023-02-01 |
| K212466 | 2021-12-09 |
| K210053 | 2021-02-05 |
| K202546 | 2020-09-29 |
| K200232 | 2020-06-23 |
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.