CoverScan
CoverScanMD is a standalone, post-processing software as a medical device (SaMD) specifically designed for the processing and analysis of magnetic resonance imaging (MRI) data. It enables…
CoverScanMD is a standalone, post-processing software as a medical device (SaMD) specifically designed for the processing and analysis of magnetic resonance imaging (MRI) data. It enables the visualisation, analysis and generation of quantitative metrics and composite images from MRI scans. CoverScanMD consists of MultiScan software and a data consolidation software which reads results from compatible SaMD’s that are independently authorised for use as medical devices. The data consolidation software compiles all the input data (metrics and image references) and produces a single JSON file output which are then used to generate quantitative multi-parametric MRI reports. The data consolidation software does not modify any input data, instead, it just appends all data into one single JSON file and a list of associated images for report generation. The report generation is done outside the CoverScanMD medical device and hence does not form part of the CoverScanMD medical device. When a referring healthcare professional requests quantitative analysis using CoverScanMD, relevant images are acquired from patients using a single MRI scan at the MR clinic and are transferred to the Perspectum Portal through established secure gateways. Perspectum trained operators use the CoverScanMD software medical device to process the MRI images and produce the quantitative metrics and composite images. The device output information is then sent to the healthcare professionals for their clinical use. CoverScanMD is only used within Perspectum’s secure infrastructure by trained operators to process clinical images and generate metrics. The metrics and composite images output by CoverScanMD are then sent to trained Healthcare Professionals who then interpret the information to make informed decisions.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (5), Beijing (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for System, Image Processing, Radiological
Record
| Listed by | Perspectum Ltd., United Kingdom |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Manufacturer |
| Record published | 2024-11-01 |
| Record revised | 2023-12-04 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.1.0 | In distribution | |
| 1.0.0 | In distribution | |
| 1.2.0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imagegrid Radiology Viewer System | Candelis, Inc. | 173 |
| Tims System | Foresight Imaging, LLC | 159 |
| System, Image Processing, Radiological | Biomet Microfixation | 146 |
| RamSoft | Ramsoft, Inc. | 65 |
| Joints | Medstrat | 62 |
| OrthoView | Meridian Technique Ltd | 54 |
| IPS | KLS-Martin L.P. | 48 |
| NovaPACS | Novarad Corp. | 42 |
| PointCloud Knee Instruments | Unik Orthopedics, Inc | 34 |
| DTX Studio™ Clinic | Nobel Biocare AB | 34 |
| Eaglesoft | Patterson Technology Center | 33 |
| Medtronic Navigation | Medtronic Navigation, Inc. | 26 |
Showing 12 of 1,109. All products under System, Image Processing, Radiological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233930 | 2024-03-13 |
| K230294 | 2023-03-03 |
| K212565 | 2022-05-19 |
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.