(127 days)
No
The document describes standard image processing and analysis tools without mentioning AI or ML algorithms.
No.
The device is a software solution for viewing, manipulating, and analyzing medical images, and its stated intended uses are for interpretation and evaluation of examinations, not for treating or preventing disease.
No.
The device is a software solution for viewing, manipulating, communicating, and storing medical images, and providing general post-processing and analysis tools, which are functionalities that support interpretation and evaluation but do not inherently provide a diagnosis themselves. The diagnosis is made by a "trained, licensed physician" who interprets the displayed images and statistics.
Yes
The device description explicitly states it is a "comprehensive software solution" and details its functions related to processing, reviewing, and analyzing MR images. There is no mention of accompanying hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the software is for "viewing, manipulation, communication, and storage of medical images" and supports "interpretation and evaluation of examinations within healthcare institutions." It focuses on processing and analyzing in vivo MR images acquired from patients.
- Device Description: The description reinforces that the software processes, reviews, and analyzes MR studies, which are images of the human body.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on biological specimens.
The software's functions, such as MR Stitching, Dynamic analysis, Image Fusion, MRS, MAPs, MR Breast Evaluation, Brain Perfusion, MR Vessel Analysis, Inner view, DCE analysis, and United Neuro, are all focused on processing and analyzing the MR images themselves, which are generated from the patient's body.
N/A
Intended Use / Indications for Use
uWS-MR is a software solution intended to be used for viewing, manipulation, and storage of medical images. It supports interpretation and evaluations within healthcare institutions. It has the following additional indications:
The MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages.
The Dynamic application is intended to provide a general post-processing tool for time course studies.
The Image Fusion application is intended to combine two different image series so that the displayed anatomical structures match in both series.
MRS (MR Spectroscopy) is intended to evaluate the molecule constitution and spatial distribution of cell metabolism. It provides a set of tools to view, process, and analyze the complex MRS data. This application supports the analysis for both SVS (Single Voxel Spectroscopy) and CSI (Chemical Shift Imaging) data.
The MAPs application is intended to provide a number of arithmetic and statistical functions for evaluating dynamic processes and images. These functions are applied to the grayscale values of medical images.
The MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced time-course images.
The Brain Perfusion application is intended to allow the visualizations in the dynamic susceptibility time series of MR datasets.
MR Vessel Analysis is intended to provide a tool for viewing, manipulating MR vascular images. The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
The DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images. The United Neuro is intended to view, manipulate, and evaluate MR neurological images.
Product codes
LLZ
Device Description
uWS-MR is a comprehensive software solution designed to process, review and analyze MR (Magnetic Resonance Imaging) studies. It can transfer images in DICOM 3.0 format over a medical imaging network or import images from external storage devices such as CD/DVDs or flash drives. These images can be functional data, as well as anatomical datasets. It can be at one or more time-points or include one or more time-frames. Multiple display formats including MIP and volume rendering and multiple statistical analysis including mean, maximum and minimum over a user-defined region is supported. A trained, licensed physician can interpret these displayed images as well as the statistics as per standard practice.
This subject device contains the following modifications/improvements in comparison to the predicate device uWS-MR:
-
Modified Indications for Use Statement;
-
Added some advanced applications:
- DCE Analysis
- United Neuro
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR (Magnetic Resonance Imaging)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare institutions
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation testing was provided to demonstrate safety and efficacy of the proposed device. This includes a hazard analysis, and the potential hazards have been classified as a moderate level of concern (LOC). These documentations include:
- Software description
- Hazard Analysis
- Software requirements specification (SRS)
- Software Architecture Description
- Software Development Environment Description
- Software Verification and Validation
- Cyber security Documents
Performance Verification:
- Performance Evaluation Report For MR DCE
- Performance Evaluation Report For MR United neuro
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K133401, K090546, K143368, K151353
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Specialist NO.2258 Chengbei Road, Jiading District Shanghai, 201807 CHINA
Re: K183164
Trade/Device Name: uWS-MR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 14, 2019 Received: March 18, 2019
Dear Xin Gao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
March 22, 2019
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara
For
Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183164
Device Name uWS-MR
Indications for Use (Describe)
uWS-MR is a software solution intended to be used for viewing, manipulation, and storage of medical images. It supports interpretation and evaluations within healthcare institutions. It has the following additional indications:
The MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages.
The Dynamic application is intended to provide a general post-processing tool for time course studies.
The Image Fusion application is intended to combine two different image series so that the displayed anatomical structures match in both series.
MRS (MR Spectroscopy) is intended to evaluate the molecule constitution and spatial distribution of cell metabolism. It provides a set of tools to view, process, and analyze the complex MRS data. This application supports the analysis for both SVS (Single Voxel Spectroscopy) and CSI (Chemical Shift Imaging) data.
The MAPs application is intended to provide a number of arithmetic and statistical functions for evaluating dynamic processes and images. These functions are applied to the grayscale values of medical images.
The MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced timecourse images.
The Brain Perfusion application is intended to allow the visualizations in the dynamic susceptibility time series of MR datasets.
MR Vessel Analysis is intended to provide a tool for viewing, manipulating MR vascular images. The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
The DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images. The United Neuro is intended to view, manipulate, and evaluate MR neurological images.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/2 description: The image contains the logo for United Imaging. The text "UNITED" is stacked on top of the text "IMAGING" in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is also in a bold font. The logo is simple and modern, and the use of bold fonts gives it a strong and confident look.
510 (k) SUMMARY
-
- Date of Preparation: November 12, 2018
2. Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Establishment Registration Number: 3011015597
Contact Person: Xin.Gao Position: Regulatory Affairs Specialist Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Identification of Proposed Device
Trade Name: uWS-MR Common Name: MR Image Post-Processing Software Model(s): uWS-MR
Regulatory Information Classification Name: Picture archiving and communications system Classification: II Product Code: LLZ Regulation Number: 21 CFR 892.2050 Review Panel: Radiology
4. Identification of Predicate Device(s)
Predicate Device 510(k) Number: K172999 Device Name: uWS-MR
Reference Device#1 510(k) Number: K133401 Device Name: syngo.MR Neurology, syngo.MR Oncology, syngo.MR BreVis and syngo.mMR General
SECTION 6 - 1 of 11
4
Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is formed by two vertical lines and a curved bottom line. There is a horizontal line in the middle of the "U" shape, creating a cross-like design within the "U".
Reference Device#2 510(k) Number: K090546 Device Name: Nordic Image Control and Evaluation (nordicICE) Software
Reference Device#3 510(k) Number: K143368 Device Name: GenIQ
Reference Device#4 510(k) Number: K151353 Device Name: syngo.MR Neurology, syngo.MR Oncology
5. Device Description
uWS-MR is a comprehensive software solution designed to process, review and analyze MR (Magnetic Resonance Imaging) studies. It can transfer images in DICOM 3.0 format over a medical imaging network or import images from external storage devices such as CD/DVDs or flash drives. These images can be functional data, as well as anatomical datasets. It can be at one or more time-points or include one or more time-frames. Multiple display formats including MIP and volume rendering and multiple statistical analysis including mean, maximum and minimum over a user-defined region is supported. A trained, licensed physician can interpret these displayed images as well as the statistics as per standard practice.
This subject device contains the following modifications/improvements in comparison to the predicate device uWS-MR:
-
Modified Indications for Use Statement;
-
Added some advanced applications:
- DCE Analysis .
- . United Neuro
6. Indications for use
uWS-MR is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:
- . The MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages.
- . The Dynamic application is intended to provide a general post-processing tool for time course studies.
- . The Image Fusion application is intended to combine two different image series so that the displayed anatomical structures match in both series.
SECTION 6 - 2 of 11
5
Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is dark blue and has a white line running vertically and horizontally through it.
- MRS (MR Spectroscopy) is intended to evaluate the molecule constitution and spatial distribution of cell metabolism. It provides a set of tools to view, process, and analyze the complex MRS data. This application supports the analysis for both SVS (Single Voxel Spectroscopy) and CSI (Chemical Shift Imaging) data.
- . The MAPs application is intended to provide a number of arithmetic and statistical functions for evaluating dynamic processes and images. These functions are applied to the grayscale values of medical images.
- . The MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced time-course images.
- . The Brain Perfusion application is intended to allow the visualization of temporal variations in the dynamic susceptibility time series of MR datasets.
- . MR Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating MR vascular images.
- . The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
- . The DCE analysis is intended to view, manipulate, and evaluate dynamic contrastenhanced MRI images.
- . The United Neuro is intended to view, manipulate, and evaluate MR neurological images
7. Summary of Technological Characteristics
uWS-MR comprises the post-processing applications for viewing, manipulation, 3D visualization, post-processing and comparison of MR images. After importing the DICOM image data into the system. the operator is able to perform image browsing and processing and can further obtain advanced information. This is identical to the predicate device.
The following tables compare the main features, principles of operation, fundamental scientific technology and intended use of uWS-MR when compared to the predicate devices.
8. Substantially Equivalent (SE) Comparison
Both the subject and predicate device have the same general information, such as Device Classification Name, Product Code, Classification Panel, etc. and visualization and
measurement technological features:
- Image communication
- Hardware /OS
- Patient Administration
- Review 2D
- Review 3D
- Filming
- Fusion
- Inner View
- Visibility
SECTION 6 - 3 of 11
6
Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is divided into two sections by a horizontal line. The logo is simple and modern, and the use of bold text and a geometric shape makes it easily recognizable.
- ROI/VOI
- MIP Display
- Compare
The subject and predicate device also have the same advanced applications in following:
- MR Brain Perfusion ●
- MR Breast Evaluation
- MR Stitching
- MR Vessel Analysis
- MRS
- MR Dynamic
- MR MAPs
The differences between the subject and the predicate device are about advanced applications is as follows:
- The subject device has added 2 new features to the predicate device. Substantial equivalence of these 2 features between the subject and the corresponding reference device is also discussed in Chapter 3.
- . DCE Analysis
- . United Neuro
- . DCE Analysis
SECTION 6 - 4 of 11
7
Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED" stacked on top of "IMAGING" in a bold, sans-serif font. To the right of the text is a stylized graphic element that appears to be a stylized letter "U" or a shield-like shape with a vertical line running through it. The color scheme is a dark teal or blue-gray against a white background.
| Item | Proposed Device
uWS-MR | Predicate Device
uWS-MR (K172999) | Remark |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | | |
| Device Classification
Name | Picture Archiving and Communications System | Picture Archiving and Communications System | Same |
| Product Code | LLZ | LLZ | Same |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Device Class | II | II | Same |
| Classification Panel | Radiology | Radiology | Same |
| Advanced Application | Yes | Yes | The subject
device includes
more
applications,
which is
discussed in the
following
sections, than the
predicate device.
This difference
will not impact
the safety and
effectiveness of
the device |
| Item | Proposed Device
uWS-MR | Predicate Device
uWS-MR (K172999) | Remark |
| Intended Use | uWS-MR is a software solution intended to be
used for viewing, manipulation, communication,
and storage of medical images. It supports
interpretation and evaluation of examinations
within healthcare institutions. It has the following
additional indications:
The MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages. The Dynamic application is intended to provide a general post-processing tool for time course studies. The Image Fusion application is intended to combine two different image series so that the displayed anatomical structures match in both series. MRS (MR Spectroscopy) is intended to evaluate the molecule constitution and spatial distribution of cell metabolism. It provides a set of tools to view, process, and analyze the complex MRS data. This application supports the analysis for both SVS (Single Voxel Spectroscopy) and CSI (Chemical Shift Imaging) data. The MAPs application is intended to provide a number of arithmetic and statistical | uWS-MR is a software solution intended to be
used for viewing, manipulation, communication,
and storage of medical images. It supports
interpretation and evaluation of examinations
within healthcare institutions. It has the following
additional indications:
The MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages. The Dynamic application is intended to provide a general post-processing tool for time course studies. The Image Fusion application is intended to combine two different image series so that the displayed anatomical structures match in both series. MRS (MR Spectroscopy) is intended to evaluate the molecule constitution and spatial distribution of cell metabolism. It provides a set of tools to view, process, and analyze the complex MRS data. This application supports the analysis for both SVS (Single Voxel Spectroscopy) and CSI (Chemical Shift Imaging) data. The MAPs application is intended to provide a number of arithmetic and statistical functions for evaluating dynamic | The intended use
is supplemented.
The subject
device includes
more
applications,
which is
discussed in the
following
sections. This
difference will
not impact the
safety and
effectiveness of
the device. |
| Item | Proposed Device
uWS-MR | Predicate Device
uWS-MR (K172999) | Remark |
| | and images. These functions are applied to
the grayscale values of medical images. | applied to the grayscale values of medical
images. | |
| | ● The MR Breast Evaluation application
provides the user a tool to calculate
parameter maps from contrast-enhanced
time-course images. | ● The MR Breast Evaluation application
provides the user a tool to calculate
parameter maps from contrast-enhanced
time-course images. | |
| | ● The Brain Perfusion application is intended
to allow the visualization of temporal
variations in the dynamic susceptibility time
series of MR datasets. | ● The Brain Perfusion application is intended
to allow the visualization of temporal
variations in the dynamic susceptibility time
series of MR datasets. | |
| | ● MR Vessel Analysis is intended to provide a
tool for viewing, manipulating, and
evaluating MR vascular images. | ● MR Vessel Analysis is intended to provide a
tool for viewing, manipulating, and
evaluating MR vascular images. | |
| | ● The Inner view application is intended to
perform a virtual camera view through
hollow structures (cavities), such as vessels. | ● The Inner view application is intended to
perform a virtual camera view through
hollow structures (cavities), such as vessels. | |
| | ● The DCE analysis is intended to view,
manipulate, and evaluate dynamic contrast-
enhanced MRI images. | | |
| | ● The United Neuro is intended to view,
manipulate, and evaluate MR neurological
images. | | |
Table 1 Comparison of general information
SECTION 6 - 5 of 11
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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized symbol that resembles a capital "U" with a horizontal line through the middle. The logo is simple and modern, and the use of bold font and a clean symbol makes it easily recognizable.
SECTION 6 - 6 of 11
9
Image /page/9/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in bold, sans-serif font. To the right of the words is a stylized symbol that appears to be a combination of the letters "U" and "I". The logo is simple and modern, with a focus on the company name and a unique symbol.
SECTION 6 - 7 of 11
10
| Application | Function name | Proposed
device | Reference
Device#1 | Reference
Device#2 | Reference
Device#3 | Remark |
|-----------------|---------------------------|--------------------|-----------------------|-------------------------------------------------------------------|-----------------------|--------|
| | | uWS-MR | syngro.MR | Nordic
Image | GenIQ
(K143368) | |
| | | | Tissue4D(K133401) | Control and
Evaluation
(nordicICE)
Software
(K090546) | | |
| DCE
Analysis | Type of imaging scans | MR | MR | MR | MR | Same |
| | Image Loading and Viewing | Yes | Yes | Yes | Yes | Same |
| | Motion Correction | Yes | Yes | / | / | Same |
| | Series Registration | Yes | Yes | / | / | Same |
| | Parametric Maps | | | | | |
| | .Ktrans | Yes | / | Yes | / | Same |
| | .kep | Yes | / | Yes | / | Same |
| | .ve | Yes | / | Yes | / | Same |
| | .vp | Yes | / | Yes | / | Same |
| | .iAUC | Yes | / | Yes | / | / |
| | .Max Slop | Yes | / | / | / | Yes |
| | .CER | Yes | / | / | / | Yes |
| | ROI Analysis | Yes | Yes | / | / | / |
| | Result Saving | Yes | Yes | / | / | Same |
| | Report | Yes | Yes | / | / | Same |
Table 2 SE Discussion for added Advanced Applications
SECTION 6 - 8 of 11
11
| Application | Function name | Proposed
device
uWS-MR | Reference
device#4:
Syngo.via
(K151353) | Remark |
|--------------|-----------------------------------|------------------------------|--------------------------------------------------|--------|
| United Neuro | Type of imaging scan | MR | MR | Same |
| | Motion correction | Yes | Yes | Same |
| | Functional activation calculation | Yes | Yes | Same |
| | Diffusion parameter analysis | Yes | Yes | Same |
| | Adjust display parameter | Yes | Yes | Same |
| | Fusion | Yes | Yes | Same |
| | Fiber tracking | Yes | Yes | Same |
| | Time-Intensity curve | Yes | Yes | Same |
| | ROI Statistics | Yes | Yes | Same |
| | Result Saving | Yes | Yes | Same |
| | Report | Yes | Yes | Same |
SECTION 6 - 9 of 11
12
Shanghai United Imaging Healthcare Co., Ltd Tel: +86 (21) 67076888 Fax : +86 (21) 67076889 www.united-imaging.com
9. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility
Not Applicable to the proposed device, because the device is stand-alone software.
Electrical Safety and Electromagnetic Compatibility (EMC)
Not Applicable to the proposed device, because the device is stand-alone software.
Software Verification and Validation
Software verification and validation testing was provided to demonstrate safety and efficacy of the proposed device. This includes a hazard analysis, and the potential hazards have been classified as a moderate level of concern (LOC). These documentations include:
- Software description
- Hazard Analysis
- · Software requirements specification (SRS)
- Software Architecture Description
- · Software Development Environment Description
- · Software Verification and Validation
- · Cyber security Documents
Animal Study
No animal study was required.
Clinical Studies
No clinical study was required.
Performance Verification
- Performance Evaluation Report For MR DCE
- . Performance Evaluation Report For MR United neuro
Product Standards and Guidance
- NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016).
- ISO 14971 Medical devices - Application of risk management to medical devices (Edition 2.0, corrected version, 2007).
- IEC 62304 Medical device software - Software life cycle processes (Edition 1.1, 2015).
SECTION 6 - 10 of 11
13
Summary
The features described in this premarket submission are supported with the results of the testing mentioned above, the uWS-MR was found to have a safety and effectiveness profile that is similar to the predicate device.
10. Substantially Equivalent (SE) Conclusion
The proposed device is equivalent to the predicate device with regard to safety and efficacy. This conclusion is based upon a comparison of intended use, technological characteristics, performance specification, device hazards as well as verification and validation results.
In summary, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.