(190 days)
No
The document describes standard image processing and analysis tools for medical images (registration, segmentation, statistical analysis, quantitative results based on predefined regions, time-activity curves). There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies summary. The analysis is based on predefined algorithms and comparisons to a database, not on learned patterns.
No
The device is a software solution for viewing, manipulating, and analyzing medical images, and for displaying and analyzing follow-up PET/CT data, dynamic PET images, and PET scans for diagnostic and evaluative purposes by physicians. It does not directly provide therapy.
Yes
The device is described as supporting "interpretation and evaluation of examinations" and provides tools for "image registration, lesion segmentation, and statistical analysis," as well as "quantitative results" and "comparison of activity of normal brain regions." These functions directly aid in the diagnosis of medical conditions.
Yes
The device description explicitly states it is a "comprehensive software solution" and details its functions related to processing, reviewing, and analyzing images, transferring images in DICOM format, and supporting various display and analysis tools. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for "viewing, manipulation, and storage of medical images" and supports "interpretation and evaluation of examinations within healthcare institutions." It focuses on analyzing in vivo imaging data (PET and CT scans of the patient's body).
- Device Description: The description reinforces this by stating it processes, reviews, and analyzes PET, CT, and PET/CT patient studies.
- IVD Definition: IVDs are defined as reagents, instruments, and systems intended for use in the in vitro examination of specimens derived from the human body to provide information for diagnostic purposes. This device does not involve the examination of in vitro specimens (like blood, urine, or tissue samples).
The software is a medical image analysis and visualization tool used to aid physicians in interpreting imaging studies performed on patients. This falls under the category of medical devices, but not specifically IVDs.
N/A
Intended Use / Indications for Use
uWS-MI is a software solution intended to be used for viewing, manipulation, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:
The PET/CT Oncology application is intended to provide tools to display and analyze the follow-up PET/CT data, with which users can do image registration, lesion segmentation, and statistical analysis.
The PET/CT Dynamic Analysis application is intended to display the dynamic PET image data and its associated timeactivity curve.
The PET/CT Brain Analysis (NeuroQ™) application is intended to analyze the brain PET scan, give quantitative results of the relative activity of 240 different brain regions, and make comparison of activity of normal brain regions in AC database.
The PET/CT Cardiac Analysis (ECTbTM) application is intended to provide cardiac short axis reconstruction, browsing function. And it also performs perfusion analysis and cardiac function analysis of the cardiac short axis.
Product codes
LLZ
Device Description
uWS-MI is a comprehensive software solution designed to process, review and analyze PET, CT and PET/CT patient 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, such as PET as well as anatomical datasets, such as CT. 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, CT, PET/CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained, licensed physician / 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
Performance Verification:
- Performance evaluation Report for PET/CT Oncology and Image Fusion
- The PET/CT Brain Analysis (NeuroQ100) application was cleared by FDA under K130451 on May 17th 2013
- The PET/CT Cardiac Analysis (ECTb™) application was cleared by FDA under K130902 on June 14th 2013.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K101749, K063324, K130451, K130902
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).
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Shanghai United Imaging Healthcare Co., Ltd. % Shumei Wang QM&RA, VP, Jiading District No. 2258 Chengbei Road Shanghai. 201807 CHINA
April 5, 2018
Re: K172998
Trade/Device Name: uWS-MI Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 30, 2018 Received: April 2, 2018
Dear Shumei Wang:
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 may, therefore, market the device, subject to the general controls provisions of the Act. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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
Robert Ochs, 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) K172998
Device Name uWS-MI
Indications for Use (Describe)
uWS-MI is a software solution intended to be used for viewing, manipulation, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:
The PET/CT Oncology application is intended to provide tools to display and analyze the follow-up PET/CT data, with which users can do image registration, lesion segmentation, and statistical analysis.
The PET/CT Dynamic Analysis application is intended to display the dynamic PET image data and its associated timeactivity curve.
The PET/CT Brain Analysis (NeuroQ™) application is intended to analyze the brain PET scan, give quantitative results of the relative activity of 240 different brain regions, and make comparison of activity of normal brain regions in AC database.
The PET/CT Cardiac Analysis (ECTbTM) application is intended to provide cardiac short axis reconstruction, browsing function. And it also performs perfusion analysis and cardiac function analysis of the cardiac short axis.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is also in a bold font. The color of the logo is a dark gray.
SECTION 3
510(k) Summary
SECTION 3 - 1 of 11
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Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the words is a stylized "U" shape, which is dark gray. The logo is simple and modern.
510 (k) SUMMARY
- Date of Preparation: 1. March 29, 2018
2. Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Establishment Registration Number: Not yet registered or the Number
Contact Person: Shumei Wang Position: QM&RA VP Tel: +86-021-67076888-6776 Fax: +86-021-67076889 Email: shumei.wang@united-imaging.com
3. Identification of Proposed Device
Trade Name: uWS-MI Common Name: PET/CT Image Post-Processing Software Model(s): uWS-MI
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: K123920 Device Name: Syngo.via
Reference Device#1 510(k) Number: K101749 Device Name: Syngo™TrueD Software
Reference Device#2 510(k) Number: K063324 Device Name: PET VCAR
SECTION 3 - 2 of 11
5
Reference Device#3 510(k) Number: K130451 Device Name: NeuroQ"M3.6
Reference Device#4 510(k) Number: K130902 Device Name: Emory Cardiac Toolbox™3.2
5. Device Description
uWS-MI is a comprehensive software solution designed to process, review and analyze PET, CT and PET/CT patient 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, such as PET as well as anatomical datasets, such as CT. 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.
6. Indications for Use
uWS-MI 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 PET/CT Oncology application is intended to provide tools to display and analyze the follow-up PET/CT data, with which users can do image registration, lesion segmentation, and statistical analysis.
- . The PET/CT Dynamic Analysis application is intended to display the dynamic PET image data and its associated time-activity curve.
- . The PET/CT Brain Analysis (NeuroQ 100) application is intended to analyze the brain PET scan, give quantitative results of the relative activity of 240 different brain regions, and make comparison of activity of normal brain regions in AC database.
- . The PET/CT Cardiac Analysis (ECTbTM) application is intended to provide cardiac short axis reconstruction, browsing function. And it also performs perfusion analysis, activity analysis and cardiac function analysis of the cardiac short axis.
SECTION 3 - 3 of 11
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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 words is a stylized "U" shape, which is also in a bold font. The logo is simple and modern, and the colors are muted.
Summary of Technological Characteristics 7.
uWS-MI is a medical diagnostic application for viewing, manipulation, 3D visualization, post-processing and comparison of medical 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 for diagnosis. 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-MI when compared to the predicate devices.
Substantially Equivalent (SE) Comparison 8.
The proposed device has similar indications for use, provides similar overall
functions and performs in a similar manner with the predicate device and reference devices.
SECTION 3 - 4 of 11
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Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font and is stacked on top of each other. To the right of the text is a stylized "U" shape, which is also in bold. The logo is simple and modern.
Table 1 SE discussion for basic functions
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| General | uWS-MI | syngo.via(K123920) | |
| 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 |
| Specification | |||
| Image | |||
| communication | Standard network protocols like | ||
| TCP/IP and standard | |||
| communication protocol DICOM. | |||
| Additional fast image. | Standard network protocols like TCP/IP | ||
| and standard communication protocol | |||
| DICOM. Additional fast image. | Same | ||
| Hardware /OS | Windows 7 | Windows 7 | Same |
| Patient | |||
| Administration | Display and manage the image data | ||
| information of all patients stored in | |||
| the database. | Display and manage the image data | ||
| information of all patients stored in the | |||
| database. | Same | ||
| Review 2D | 2D Review consists of basic | ||
| processing of the 2D images, e.g. | |||
| rotation, scaling, translation, | |||
| windowing, and measurements. | 2D Review consists of basic processing | ||
| of the 2D images, e.g. rotation, scaling, | |||
| translation, windowing, and | |||
| measurements. | Same | ||
| Review 3D | 3D Review consist of | 3D Review consist of functionalities for | Same |
| Item | Proposed Device | Predicate Device | |
| syngo.via(K123920) | Remark | ||
| uWS-MI | |||
| functionalities for displaying and | |||
| processing image in the 3D form, | |||
| e.g. VR, CPR, MPR, MIP, etc. The | |||
| module also includes tools for VOI | |||
| analysis. | displaying and processing image in the | ||
| 3D form, e.g. VR, CPR, MPR, MIP, etc. | |||
| The module also includes tools for VOI | |||
| analysis. | |||
| Filming | Filming is a module dedicated for | ||
| image printing. The print tools | |||
| provide layout editing for both | |||
| single images and series. | Filming is a module dedicated for image | ||
| printing. The print tools provide layout | |||
| editing for both single images and series. | Same | ||
| Fusion | Including Auto registration, | ||
| Manual registration, Spot | |||
| registration | Including Auto registration, Manual | ||
| registration, Spot registration | Same | ||
| Inner View | Inner view the vessel , colon , | ||
| trachea | Inner view the vessel , colon , trachea | Same | |
| Visibility | User-defined the display property of | ||
| fused image: Adjustment of preset | |||
| of T/B value; Adjustment of the | |||
| fused rate; Adjustment of pse | User-defined the display property of | ||
| fused image: Adjustment of preset of T/B | |||
| value; Adjustment of the fused rate; | |||
| Adjustment of pse | Same | ||
| ROI/VOI | Plotting ROI or VOI, and obtaining | ||
| the maximum activity value, the | |||
| minimum activity value, mean | |||
| activity value, the volume/area of | |||
| region, and the maximum diameter | |||
| of volume, peak activity value; | Plotting ROI or VOI, and obtaining the | ||
| maximum activity value, the minimum | |||
| activity value, mean activity value, the | |||
| volume/area of region, and the maximum | |||
| diameter of volume, peak activity value; | Same | ||
| MIP Display | The image can be displayed as MIP | ||
| and rotating play | The image can be displayed as MIP and | ||
| rotating play | Same | ||
| Compare | Load two studies to compare | Load two studies to compare | Same |
SECTION 3 - 5 of 11
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SECTION 3 - 6 of 11
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Table 2 SE discussion for advanced applications
| Application | Function name | Propose
d device
uWS-MI | Reference
device#1:
SyngoTM TrueD
Software
(K101749) | Reference
device#2:
GE PET
VCAR
(K063324) | Reference
device#3:
NeuroqTM3.6
(K130451) | Reference
device#4:
Syntermed
Emory
Cardiac
ToolboxTM3.
2 (K130902) | Remark |
|---------------------------------------------------------------|------------------------------------------------------|-------------------------------|------------------------------------------------------------------|-------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PET/CT
Dynamic
Analysis | Reframe/Rebin | Yes | Do not have the
function of data
reframe | / | / | / | The Reframe/Rebin
module is applied
to generate
combined data of
any time phase
defined by the user.
This difference will
not impact the
safety and
effectiveness of the
device. |
| | ROI Analysis | Yes | Yes | / | / | / | Same |
| | Pseudo color | Yes | Yes | / | / | / | Same |
| | Automatic cine | Yes | Yes | / | / | / | Same |
| | Curve Analysis | Yes | Yes | / | / | / | Same |
| | Table Statistics | Yes | Yes | / | / | / | Same |
| | Save | Yes | Yes | / | / | / | Same |
| | Filming | Yes | Yes | / | / | / | Same |
| PET/CT
Oncology | Compare
display | Yes | / | Yes | / | / | Same |
| | Auto
registration | Yes | / | Yes | / | / | Same |
| Application | Function name | Propose
d device
uWS-MI | Reference
device#1:
SyngoTMTrueD
Software
(K101749) | Reference
device#2:
GE PET
VCAR
(K063324) | Reference
device#3:
NeuroqTM3.6
(K130451) | Reference
device#4:
Syntermed
Emory
Cardiac
ToolboxTM3.
2 (K130902) | Remark |
| | Manual
registration | Yes | / | Yes | / | / | Same |
| | Fix
Segmentation | Yes | / | Yes | / | / | Same |
| | Adaptive
Segmentation | Yes | / | Yes | / | / | Same |
| | Spread | Yes | / | Yes | / | / | Same |
| | Statistical
Analysis | Yes | / | Yes | / | / | Same |
| | Save | Yes | / | Yes | / | / | Same |
| | Reformat | Yes | / | / | Yes | / | Same |
| | Quality Control | Yes | / | / | Yes | / | Same |
| | Slice Display | Yes | / | / | Yes | / | Same |
| PET/CT
Brain
Analysis | Compare | Yes | / | / | Yes | / | Same |
| | PET/CT Fusion | Yes | / | / | Yes | / | Same |
| | EQuAL analysis | Yes | / | / | Yes | / | Same |
| (NeuroqTM3.
6) | AmyQ | Yes | / | / | Yes | / | Same |
| | Save results,
Capture
region/display ,
Exit | Yes | / | / | Yes | / | Same |
| PET/CT | Reconstruction | Yes | / | / | / | Yes | Same |
| Application | Function name | Propose
d device
uWS-MI | Reference
device#1:
SyngoTMTrueD
Software
(K101749) | Reference
device#2:
GE PET
VCAR
(K063324) | Reference
device#3:
NeuroqTM3.6
(K130451) | Reference
device#4:
Syntermed
Emory
Cardiac
ToolboxTM3.
2 (K130902) | Remark |
| Cardiac
Analysis
(Emory
Cardiac
ToolboxTM3.
2) | SSS | Yes | / | / | / | Yes | Same |
| | Polor Maps | Yes | / | / | / | Yes | Same |
| | Perfusion
Analysis | Yes | / | / | / | Yes | Same |
| | Viability
Analysis | Yes | / | / | / | Yes | Same |
| | Functional
Analysis | Yes | / | / | / | Yes | Same |
| | Save results,
Capture
region/display ,
Exit | Yes | / | / | / | Yes | Same |
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Image /page/10/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark teal in color. The logo is simple and modern in design.
SECTION 3 - 8 of 11
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Image /page/11/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark teal in color. The logo is simple and modern in design.
SECTION 3 - 9 of 11
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Image /page/12/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized, dark gray icon that resembles a shield or a letter "U" with a horizontal line through the middle. The overall design is clean and modern.
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 PET/CT Oncology and Image Fusion
- . The PET/CT Brain Analysis (NeuroQ100) application was cleared by FDA under K130451 on May 17th 2013
- The PET/CT Cardiac Analysis (ECTb™) application was cleared by FDA under . K130902 on June 14th 2013.
Product Standards and Guidance
- NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016).
SECTION 3 - 10 of 11
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Image /page/13/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is also in a bold, sans-serif font. The color of the text and the "U" shape is a dark teal.
- 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).
Summary
The features described in this premarket submission are supported with the results of the testing mentioned above. The uWS-MI 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.