(406 days)
K123920 syngo.via
No
The document describes standard image processing and analysis tools without mentioning AI or ML. The performance studies listed are for specific applications, not necessarily indicative of AI/ML model validation.
No
The device is a software solution for viewing, manipulating, and analyzing medical images, and for providing tools to support diagnosis and evaluation. It does not directly treat or prevent a disease, nor does it restore, modify, or correct body function.
Yes
The device aids in the interpretation and evaluation of medical images for diagnostic purposes, such as oncology, colon analysis, and lung nodule assessment.
Yes
The device description explicitly states "uWS-CT is a comprehensive software solution". While it interacts with medical images and potentially hardware for storage and display, the core device being described and regulated is the software itself. The performance studies listed are also focused on the software's performance in analyzing images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this software is for viewing, manipulating, and analyzing medical images (specifically CT scans) of anatomical structures within the body. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The focus is on image interpretation and analysis. The software provides tools for visualizing, segmenting, and quantifying features within the images, which are then interpreted by a trained physician. This is distinct from the analytical and diagnostic processes performed by IVDs on biological specimens.
The device falls under the category of medical image processing and analysis software, which is regulated differently than IVDs.
N/A
Intended Use / Indications for Use
uWS-CT 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 CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing a tool for the user to perform the segmentation of suspicious lesions in lung or liver. The CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon.
The CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw. The CT Lung Density application is intended to provide the user a number of density parameters and structure information for evaluating tomogram scans of the lung.
The CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies.
The CT Vessel Analysis application is intended to provide a tool for viewing, manipulating CT vascular images.
The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
uWS-CT is a comprehensive software solution designed to process, review and analyze CT 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
lung or liver, colon, jaw, lung, thoracic CT images, vessels
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 (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). Key results include:
- Performance Evaluation Report For CT Lung Nodule
- Performance Evaluation Report For CT Oncology
- Performance Evaluation Report For CT Colonoscopy
- Performance Evaluation Report For CT Fusion
- Performance Evaluation Report For CT Inner View
- Performance Evaluation Report For CT Vessel
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K123920 syngo.via
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K033326, K162025, K081985, K023785
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo, which features a stylized human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration written in blue text.
November 7, 2018
Shanghai United Imaging Healthcare Co., Ltd. % Shumei Wang QM&RA VP No.2258 Chengbei Road, Jiading District Shanghai, 201807 CHINA
Re: K173001
Trade/Device Name: uWS-CT Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: October 9, 2018 Received: October 10, 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. Although this letter refers to your product as a device, please be aware 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/cfpmp/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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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.
Hole 2. Nils
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) K173001
Device Name uWS-CT
Indications for Use (Describe)
uWS-CT 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 CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing a tool for the user to perform the segmentation of suspicious lesions in lung or liver. The CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon.
The CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw. The CT Lung Density application is intended to provide the user a number of density parameters and structure information for evaluating tomogram scans of the lung.
The CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies.
The CT Vessel Analysis application is intended to provide a tool for viewing, manipulating CT vascular images.
The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
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 words "UNITED IMAGING" are in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, also in a bold, sans-serif font. The color of the text and symbol is a dark teal.
510 (k) SUMMARY
K173001
Date of Preparation: 1. March 26, 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 for 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-CT Common Name: CT Image Post-Processing Software Model(s): uWS-CT
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: K033326 Device Name: "Philips Plus" CT Scanner
Reference device#2 510(k) Number: K162025 Device Name: IntelliSpace Portal Platform
SECTION 2 - 2 of 11
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Image /page/4/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 "U" shape, which is also in bold. The logo is simple and modern, and the colors are muted.
Reference device#3 510(k) Number: K081985 Device Name: AW SERVER
Reference device#4 510(k) Number: K023785 Device Name: Lung Nodule Assessment and Comparison Option (LNA)
Device Description 5.
uWS-CT is a comprehensive software solution designed to process, review and analyze CT 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.
Indications for use 6.
uWS-CT 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 CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing a tool for the user to perform the segmentation and volumetric evaluation of suspicious lesions in lung or liver.
- The CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon.
- The CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw.
- . The CT Lung Density application is intended to provide the user a number of density parameters and structure information for evaluating tomogram scans of the lung.
- . The CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies.
SECTION 2 - 3 of 11
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Image /page/5/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, also in a bold font. The color of the text and the "U" shape is a dark teal.
- The CT Vessel Analysis application is intended to provide a tool for viewing. manipulating, and evaluating CT vascular images.
- . The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
7. Summary of Technological Characteristics
uWS-CT 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-CT when compared to the predicate devices.
8. Substantially Equivalent (SE) Comparison
The proposed device has similar indications for use and overall function and performs in a similar manner with respect to, display, review and processing applications with predicate device and reference device.
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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other and are in a bold, sans-serif font. To the right of the words is a stylized "U" shape that is dark blue. The logo is simple and modern.
Table 1 SE Discussion for basic functions
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| uWS-CT | syngo.via(K123920) | ||
| 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 |
| 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 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. | 3D Review consist of 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. | Same | ||
| 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 registration, Manual registration, Spot | ||
| registration | Including registration, Manual registration, Spot | ||
| registration | Same | ||
| Inner View | Inner view the vessel, colon, trachea | Inner view the vessel, colon, trachea | Same |
| Item | Proposed Device | Predicate Device | Remark |
| uWS-CT | syngo. via(K123920) | ||
| Visibility | User-defined the display property of fused | User-defined the display property of fused image: | Same |
| image: Adjustment of preset of T/B value; | Adjustment of preset of T/B value; Adjustment of | ||
| Adjustment of the fused rate; Adjustment of pse | the fused rate; Adjustment of pse | ||
| ROI/VOI | Plotting ROI or VOI, and obtaining the | Plotting ROI or VOI, and obtaining the maximum | Same |
| maximum activity value, the minimum activity | activity value, the minimum activity value, mean | ||
| value, mean activity value, the volume/area of | activity value, the volume/area of region, and the | ||
| region, and the maximum diameter of volume, | maximum diameter of volume, peak activity value; | ||
| peak activity value; | |||
| MIP Display | The image can be displayed as MIP and rotating | The image can be displayed as MIP and rotating | Same |
| play | play | ||
| Compare | Load two studies to compare. | Load two studies to compare. | Same |
SECTION 2 - 5 of 11
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Table 2 SE discussion for additional applications
| Application | Function name | Proposed
device
uWS-CT | Predicate
Device
syngo. via
(K123920) | Reference
device#1:
"Philips Plus"
CT Scanner
(K033326) | Reference
device#2:
IntelliSpace
Portal
Platform
(K162025) | Reference
device#3:
AW
SERVER
(K081985) | Reference
device#4:
Lung Nodule
Assessment and
Comparison
Option (LNA)
(K023785) | Remark |
|--------------------------|-----------------------------------------------------|------------------------------|------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------------------------------------------------|--------|
| CT Lung
density | Lung and Trachea
Segmentation | Yes | / | Yes | / | / | / | Same |
| | Calculation of Lung
Density | Yes | / | Yes | / | / | / | Same |
| | Histogram Analysis | Yes | / | Yes | / | / | / | Same |
| | Table Statistics | Yes | / | Yes | / | / | / | Same |
| | VRT Protocol Display | Yes | / | Yes | / | / | / | Same |
| | Save, Report, Print | Yes | / | Yes | / | / | / | Same |
| Application | Function name | Proposed
device
uWS-CT | Predicate
Device
syngo. via
(K123920) | Reference
device#1:
"Philips Plus"
CT Scanner
(K033326) | Reference
device#2:
IntelliSpace
Portal
Platform
(K162025) | Reference
device#3:
AW
SERVER
(K081985) | Reference
device#4:
Lung Nodule
Assessment and
Comparison
Option (LNA)
(K023785) | Remark |
| CT Oncology | Compare display | Yes | / | Yes | / | / | / | Same |
| | Registration | Yes | / | Yes | / | / | / | Same |
| | Manual registration | Yes | / | Yes | / | / | / | Same |
| | lung nodules
segmentation | Yes | / | Yes | / | / | / | Same |
| | liver lesions
segmentation | Yes | / | Yes | / | / | / | Same |
| | Spread | Yes | / | Yes | / | / | / | Same |
| | Statistical Analysis | Yes | / | Yes | / | / | / | Same |
| | Save, Report, Print | Yes | / | Yes | / | / | / | Same |
| CT Dental
Application | Setting Reference
Line in 3D MIP
Image | Yes | / | Yes | / | / | / | Same |
| | Plotting Panoramic
Curve | Yes | // | Yes | / | / | / | Same |
| | Marking Nerve Lines | Yes | / | Yes | / | / | / | Same |
| | Sectional View
Analysis | Yes | / | Yes | / | / | / | Same |
| | Dental VRT Display | Yes | / | Yes | / | / | / | Same |
| | Save | Yes | / | Yes | / | / | / | Same |
| | Print | Yes | / | Yes | / | / | / | Same |
| | Report | Yes | / | Yes | / | / | / | Same |
| | Pre-processing | Yes | / | Yes | / | / | / | Same |
| Application | Function name | Proposed
device
uWS-CT | Predicate
Device
syngo. via
(K123920) | Reference
device#1:
"Philips Plus"
CT Scanner
(K033326) | Reference
device#2:
IntelliSpace
Portal
Platform
(K162025) | Reference
device#3:
AW
SERVER
(K081985) | Reference
device#4:
Lung Nodule
Assessment and
Comparison
Option (LNA)
(K023785) | Remark |
| CT Colon
Analysis | Electronic Colon
Cleansing | Yes | / | Yes | / | / | / | Same |
| | Manual Polyps
Labeling | Yes | / | Yes | / | / | / | Same |
| | Polyps' Quantitative
Calculation and
Analysis | Yes | / | Yes | / | / | / | Same |
| | Virtual Endoscopy | Yes | / | Yes | / | / | / | Same |
| | Multi-Views Display | Yes | / | Yes | / | / | / | Same |
| | Colon edit | Yes | / | Yes | / | / | / | Same |
| | Save, Report, Print | Yes | / | Yes | / | / | / | Same |
| CT Vessel
Analysis | Blood Vessel Center
Lines Extraction | Yes | / | Yes | / | / | / | Same |
| | VOI Segmentation | Yes | / | Yes | / | / | / | Same |
| | Organizations
Management | Yes | / | Yes | / | / | / | Same |
| | Vessel Tracking | Yes | / | Yes | / | / | / | Same |
| | Filter floaters | Yes | / | Yes | / | / | / | Same |
| | Save, Report, Print | Yes | / | Yes | / | / | / | Same |
| | One click Bones
Removal | Yes | / | / | Yes | / | / | Same |
| | DSA Bone Removal | Yes | Yes | / | / | / | / | Same |
| | Vascular
Measurement | Yes | / | / | / | Yes | / | Same |
| Application | Function name | Proposed
device
uWS-CT | Predicate
Device
syngo. via
(K123920) | Reference
device#1:
"Philips Plus"
CT Scanner
(K033326) | Reference
device#2:
IntelliSpace
Portal
Platform
(K162025) | Reference
device#3:
AW
SERVER
(K081985) | Reference
device#4:
Lung Nodule
Assessment and
Comparison
Option (LNA)
(K023785) | Remark |
| CT Lung
Nodule | Mark the nodule | Yes | / | Yes | / | / | / | Same |
| | Compare the study | Yes | / | Yes | / | / | / | Same |
| | Save, Report, Print | Yes | / | Yes | / | / | / | Same |
| | Lung Segmentation | Yes | / | / | / | / | Yes | Same |
| | Nodule Segmentation | Yes | / | / | / | / | Yes | Same |
| | Measurement | Yes | / | / | / | / | Yes | Same |
SECTION 2 - 6 of 11
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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is written in bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is dark blue. The logo is simple and modern.
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Image /page/9/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font, with "UNITED" stacked on top of "IMAGING". To the right of the text is a stylized "U" symbol, which is dark blue. The logo is simple and modern.
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Image /page/10/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark blue and has a white line running vertically through the center.
SECTION 2 - 9 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" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized symbol that resembles a shield or a letter "U" with a horizontal line through the middle. The color of the text and symbol is a dark gray or teal.
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). Those 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 CT Lung Nodule
- Performance Evaluation Report For CT Oncology
- Performance Evaluation Report For CT Colonoscopy
- Performance Evaluation Report For CT Fusion
- Performance Evaluation Report For CT Inner View
- . Performance Evaluation Report For CT Vessel
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Image /page/12/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font, stacked on two lines. To the right of the text is a stylized icon that resembles the letter "U" with a horizontal line through the middle, creating a negative space "I" shape. The logo is simple and modern in design.
Other 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).
Summary
The features described in this premarket submission are supported with the results of the testing mentioned above; the uWS-CT was found to have a safety and effectiveness profile that is similar to the predicate device and reference devices.
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 and reference devices.