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…

Registry build 21.09.26

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.

16manufacturers in China registered for this device type
3catalogue numbers in this listing
3510(k) clearances naming this product code

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.

Chinese manufacturers registered for FDA product code LLZ
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

Regulatory record for CoverScan
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

Specifications
MRI safety MR Conditional
Prescription Prescription only

Catalogue Numbers

Catalogue numbers for CoverScan
Catalogue number Size Status
1.1.0 In distribution
1.0.0 In distribution
1.2.0 In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer