Scenium
The FDA filing names Scenium as a neurology software application within syngo.via MI Workflows and describes the software as a multi-modality postprocessing device. The filing states that…
The FDA filing names Scenium as a neurology software application within syngo.via MI Workflows and describes the software as a multi-modality postprocessing device.
The filing states that the MI workflows handle medical images from one or more modalities and time points, including functional PET or nuclear-medicine data.
Device Function and Design
The filing describes Scenium VE60 as supporting a tau workflow in its MI Neuro Cortical Analysis workflow. It also says Scenium already supported amyloid PET quantification and cortical SUVR calculations relative to a reference region.
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 | Siemens Medical Solutions USA, Inc., United States |
|---|---|
| FDA product code | QIH |
| Device type | Automated Radiological Image Processing Software |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K232000 |
| Record published | 2023-12-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11431591 | In distribution | |
| 11589501 | In distribution | |
| 11431562 | 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 |
| 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 |
| Tomtec-Arena | Tomtec Imaging Systems GMBH | 3 |
Showing 12 of 147. All products under Automated Radiological Image Processing Software
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253786 | 2026-06-25 |
| K254184 | 2026-04-29 |
| K254016 | 2026-02-10 |
| K251528 | 2025-07-03 |
| K242275 | 2024-08-30 |
| K242300 | 2024-08-30 |
| K232000 | 2023-11-28 |
| K222428 | 2022-11-14 |
| K222172 | 2022-08-19 |
| K211459 | 2021-06-10 |
| K201195 | 2020-11-18 |
| K193283 | 2020-07-30 |
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.