Mpxa
MPXA-2000 is stand-alone software for viewing and quantifying X-ray angiographic images of the coronary arteries. It automatically detects vessel contours and calculates dimensions from the…
MPXA-2000 is stand-alone software for viewing and quantifying X-ray angiographic images of the coronary arteries. It automatically detects vessel contours and calculates dimensions from the segmented vessels, with results presented for user review and editing.
The filing indicates use in clinical settings to support calculations on coronary angiograms for adult patients with coronary artery disease. Cardiologists and radiologists use the analysis results to support clinical decisions concerning coronary arteries; the output is not intended as the sole basis for diagnosis.
Listed Item
Automated Radiological Image Processing Software
Image Analysis Workflow
The software accepts DICOM-compliant X-ray angiographic images. Its automatic contour detection and vessel measurements are reviewed and may be manually edited by the user. The FDA summary says resulting quantified information can support clinical decisions or evaluation of treatment, while responsibility remains with clinicians.
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 | Medipixel, Inc., South Korea |
|---|---|
| FDA product code | QIH |
| Device type | Automated Radiological Image Processing Software |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Manufacturer |
| 510(k) | K222036 |
| Record published | 2023-05-04 |
| Record revised | 2024-06-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V1.0.0 | 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 |
|---|---|
| K222036 | 2023-03-22 |
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.