ZED Link

K180549 · Zed Technologies · LLZ · Apr 12, 2018 · Radiology

Device Facts

• Record ID: K180549
• Device Name: ZED Link
• Applicant: Zed Technologies
• Product Code: LLZ · Radiology
• Decision Date: Apr 12, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

ZED LINK™, is an image management system whose intended use is to provide scalable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, retrieve and display images and data from all image modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation" and will include standard features and other tools for analyzing mammography images. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. ZED LINK™, is not intended for diagnostic image review on mobile devices. Typical users of this system are doctors and health care professionals.

Device Story

ZED LINK™ is a web-based PACS image management system for hospitals/clinics. It ingests DICOM images from modalities (CT, MR, US, PET, etc.) and integrates with HIS/RIS via HL7. Operated by radiologists, technicians, and physicians, it provides a platform for image archiving, retrieval, and display. Features include multi-planar reconstruction (MPR), hanging protocols, worklist management, and annotation tools. Users access the system via web browsers; roaming profiles maintain personal settings. The system supports teleradiology and remote reporting. Output is displayed on clinical monitors for diagnostic interpretation by physicians. Benefits include streamlined radiology workflow, remote access to patient data, and replacement of film-based archives. Security is maintained via TLS, digital signatures, role-based access, and audit trails.

Clinical Evidence

Bench testing only. Verification and validation testing were conducted to evaluate input/output functions and operational modes against pre-determined acceptance criteria. Results confirmed the system meets all safety and performance requirements as documented in the validation test plan.

Technological Characteristics

Software-based PACS application. Operates on web browsers (Chrome, Edge, Firefox, Safari, Opera). Uses MS SQL database. Supports DICOM 3.0, HL7, and IHE security profiles. Features include MPR, GSPS, and web-based deployment with automatic updates. Security includes TLS, SSL, 128-bit encryption, and role-based access control. Does not contact patients; requires human intervention for interpretation.

Indications for Use

Indicated for use by doctors and healthcare professionals in hospitals and clinical institutions to archive, retrieve, and display medical images (CR, CT, DR, MR, etc.) and structured reports. Includes mammography image display for primary diagnosis using pre-processed DICOM 'For Presentation' images on FDA-compliant monitors. Contraindicated for primary diagnostic review of lossy compressed mammographic images, digitized film screen images, and mobile device displays.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• BOX DICOM Viewer (K151957)

Submission Summary (Full Text)

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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.

Zed Technologies % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071 April 12, 2018

Re: K180549

Trade/Device Name: ZED LINK™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 21, 2018 Received: March 1, 2018

Dear Mr. Alletto:

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.

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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 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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K180549

Device Name ZED LINK™

#### Indications for Use (Describe)

ZED LINK™, is an image management system whose intended use is to provide scalable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, retrieve and display images and data from all image modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation" and will include standard features and other tools for analyzing mammography images. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. ZED LINK™, is not intended for diagnostic image review on mobile devices. Typical users of this system are doctors and health care professionals.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

#### Date Prepared:

March 30, 2018

### Submitter's Information: 21 CFR 807.92(a)(1)

Mr. Ronald Li, Co-Founder and CTO Zed Technologies, Office 105, 12 Yarra St South Yarra VIC 3141 Australia Tel [phone] Email: [e-mail]

#### Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

| Trade Name: | ZED LINK™ |
|----------------------|--------------------------------------------|
| Common Name: | Picture, archive and communications system |
| Classification Name: | System, Image Processing, Radiological |
| Product Code: | LLZ |

### Predicate Device: 21 CFR 807. 92(a)(3)

| Device Classification Name | system, image processing, radiological |
|------------------------------|----------------------------------------|
| 510(k) Number | K151957 |
| Device Name | BOX DICOM Viewer |
| Regulation Number | 892.2050 |
| Classification Product Code | LLZ |
| Date Received | 07/16/2015 |
| Decision Date | 09/01/2015 |
| Decision | substantially equivalent (SE) |
| Regulation Medical Specialty | Radiology |
| 510k Review Panel | Radiology |
| summary | summary |
| Reviewed by Third Party | No |
| Combination Product | No |

### Device Description: 21 CFR 807 92(a)(4)

#### ZED LINK™ has four main uses:

- . Hard copy replacement: Replaces hard-copy media for managing medical images, such as film archives.
- Remote access: Expands the possibilities of conventional systems by providing . capabilities of off-site viewing and reporting (distance education, tele review). It enables practitioners in different physical locations to access the same information simultaneously for teleradiology.
- . Electronic image integration platform: Provides the electronic platform for radiology images interfacing with other medical automation systems such as Hospital Information System (HIS), Electronic Medical Record (EMR), Practice Management Software, and Radiology Information System (RIS).

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- . Radiology Workflow Management: Used by radiology personnel to manage the workflow of patient exams.
### Typical Workflow

- The typical Workflow starts when a patient arrives at the Medical Institution: Hospital or ● diagnostic center to get a radiological exam.
- The Medical Institution could have a modality, like an MRI Machine or X-Ray and start by . registering the patient information like name and date of birth.
- Once the patient information is registered, the Modality User (not part of ZED LINK™) . can start the acquisition of the images.
- After taking the images, images are on the network and the radiologist can view images . using ZED LINK™, add annotations, and write a report.
- . Finally, exam can be forwarded, and/or the report viewed by others.
- The figure below shows the typical workflow diagram. ●

### Cyber Security/Web-Based Deployment/Smart Update

The ZED LINK™, is a web-based solution that gives easy accessibility through a web browser and a software update can be automatically performed whenever a user logs in. Therefore, the User will access the latest version of ZED LINK™, with every log-on and reduces the risk of cyber security issues Also, if cyber security issues are found or suspected, the software can be modification is available the next time the User logs into the system.

### Image Distribution & Viewing

- Users can access image data and Viewer tools via Internet at any time. ●
- . Provides user-defined application profile for technicians, radiologists, and outpatient physicians with customized tools for each user type.
- . Users can access HIS / RIS data through HL7 interface.
- Provides advanced hanging protocol and worklist tools preset to suit each user; optimal Viewer environment is guaranteed for convenient usage experience.
- . With ZED LINK™, roaming profile, users can access PACS Viewer from anywhere and find their personal settings intact.
- Instant, effective communication tool for technicians, radiologists, and emergency ● physicians, is provided to ensure smoother, quicker treatment process.
- . Provides DICOM-compatible Grayscale Softcopy Presentation State [GSPS] which enables important dictation data to be stored and shared in DICOM format without any data loss.
- . Automatic updates of name labels on both current and related exams allow for easier analysis.
- . Automatic marking of scout lines on selected images; users can quickly and intuitively select scout images.
- . Users can easily save and re-access worked images in their current states, using Demo Folder and 2D Job Save function.

### Security and Privacy

- . TLS DICOM.
- Digital signature.
- Control by user accounts, authority and modality authority.
- . Provides accurate inspection information through 6-Level Log Reinforcement & Audit Trail.

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- . Detailed logs about invalid DICOM IOD.
- . Safe and coded web protocol: 128 bit and SSL code available.
- . Creates a reliable event log to patient information through user authentication that is compliant with the IHE security profile.
- Through role-based access controls, administrators can define specific permissions . and access levels for users and user groups.
- . Manages log-in and password to internal and external access.
- Managers can make limitations to every user level via the auto-logoff function. ●
- Provides inspection, report and statistics compliant with HIPAA security to every . record.

### Indications for Use: 21 CFR 807 92(a)(5)

ZED LINK™, is an image management system whose intended use is to provide scalable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all image modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation" and will include standard features and other tools for analyzing mammography images. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. ZED LINK™, is not intended for diagnostic image review on mobile devices. Typical users of this system are doctors and health care professionals.

### Technological Characteristics: 21 CFR 807 92(a)(6)

ZED LINK™, is a software application that handles medical digital images. The device does not contact the patient, nor does it control any life sustaining devices.

A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed. The universal format for PACS image storage and transfer is DICOM, (Digital Imaging and Communications in Medicine). Non-image data, such as scanned documents, may be incorporated using consumer industry standard formats like PDF (Portable Document Format), once encapsulated in DICOM. The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use.

The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices. Both systems have been developed to replace traditional film handling in radiology. The 2 devices are substantially equivalent in the areas of design, architecture, general function, application, and intended use.

The following table compares the predicate device and new device. Any differences between the predicate and the new device has no impact on safety or efficacy of the new device and does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.

| Ref<br># | Functionality | Predicate: BOX DICOM<br>Viewer K151957 | Subject Device: ZED<br>LINKTM | If different, Impact on Safety<br>and or Efficacy |
|----------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Web Browser | Google Chrome for all<br>features.<br>Microsoft Internet | Our viewer supports<br>Microsoft Internet<br>Explorer, Microsoft | Yes, there are differences. The<br>difference is that the subject<br>device covers additional Web |
| Ref<br># | Functionality | Predicate: BOX DICOM<br>Viewer K151957 | Subject Device: ZED<br>LINK TM | If different, Impact on Safety<br>and or Efficacy |
| 1 | | Explorer &<br>Mozilla Firefox for<br>features except the<br>DICOM Viewer | Edge, Mozilla Firefox,<br>Google Chrome, Apple<br>Safari and Opera for<br>all features. | Browsers and they can be used<br>for all device features. |
| 2 | Intended use | Acquiring, viewing,<br>editing and storing<br>radiographs and related<br>patient's images | Same as predicate | No difference |
| 3 | Intended user | Radiologist & qualified<br>medical personnel | Same as predicate | No difference |
| 4 | Network | 10/100/100 Ethernet | Same as predicate | No difference |
| 5 | Monitor | Above 19inch monitor<br>(Using 1280x1024) | Same as predicate | No difference |
| 6 | User<br>interaction/input | Same, Using 1280x1024 | Same as predicate | No difference |
| 7 | Import / export<br>images | Yes | Same as predicate | No difference |
| 8 | Acquisition<br>devices | CT, MR, US, PET | Same as predicate | No difference |
| 9 | Image<br>organization | Patient ID, Name, study<br>instance UID | Same as predicate | No difference |
| 10 | Image search<br>available | Same | Same as predicate | No difference |
| 11 | Image storage | Yes | Same as predicate | No difference |
| 12 | Database<br>software | MySQL | MS SQL | No difference |
| 13 | Greyscale<br>Image<br>Rendering | Yes | Same as predicate | No difference |
| 14 | RGB Image<br>Rendering | Yes | Same as predicate | No difference |
| 15 | Localizer Lines | Yes | Same as predicate | No difference |
| 16 | Localizer Point | Yes | Same as predicate | No difference |
| 17 | Orientation<br>Markers | Yes | Same as predicate | No difference |
| 18 | Distance<br>Markers | Yes | Same as predicate | No difference |
| Ref<br># | Functionality | Predicate: BOX DICOM<br>Viewer K151957 | Subject Device: ZED<br>LINK TM | If different, Impact on Safety<br>and or Efficacy |
| 19 | Study Data<br>Overlays | Yes | Same as predicate | No difference |
| 20 | Stack<br>Navigation | Yes | Same as predicate | No difference |
| 21 | Window Level | Yes | Same as predicate | No difference |
| 22 | Zoom in on<br>images | Yes | Same as predicate | No difference |
| 23 | Panning | Yes | Same as predicate | No difference |
| 24 | Horizontal/Vertic<br>al Flip | Yes | Same as predicate | No difference |
| 25 | Clockwise/Coun<br>terclockwise<br>rotate | Yes | No | Yes, there is a difference. The<br>difference does not raise any<br>new potential safety risks and<br>therefore, there is no impact on<br>safety or efficacy for the<br>subject device. |
| 26 | Invert image | Yes | Same as predicate | No difference |
| 27 | Text Annotation | Yes | Same as predicate | No difference |
| 28 | Area<br>measurement<br>annotation | Yes | No | Yes, there is a difference. The<br>difference does not raise any<br>new potential safety risks and<br>therefore, there is no impact on<br>safety or efficacy for the subject<br>device. |
| 29 | Angle<br>measurement<br>annotation | Yes | Same as predicate | No difference |
| 30 | Cobb Angle<br>Measurement<br>Annotation | Yes | Same as predicate | No difference |
| 31 | Image<br>annotation | Yes | Same as predicate | No difference |
| 32 | Security | Yes | Same as predicate | No difference |
| 33 | DICOM 3.0<br>conformance | Yes | Same as predicate | No difference |
| 34 | Worklist | Yes | Same as predicate | No difference |
| Ref<br># | Functionality | Predicate: BOX DICOM<br>Viewer K151957 | Subject Device: ZED<br>LINK TM | If different, Impact on Safety<br>and or Efficacy |
| 35 | Thumbnail<br>viewing | Yes, thumbnails on<br>preview, small, medium<br>and large | Same as predicate | No difference |
| 36 | Login | Yes | Same as predicate | No difference |
| 37 | Audit | Yes, a tool to view<br>access logs in real time. | Same as predicate | No difference |
| 38 | WebGL<br>rendering<br>optimizations | No hardware<br>acceleration. | Same as predicate | No difference |
| 39 | Support for high<br>resolution<br>Retina displays | Pixelated display on<br>high-DPI displays only<br>(i.e., "Retina Displays"). | Same as predicate | No difference |
| 40 | Keyboard<br>shortcuts for<br>tools and all<br>annotation types | Limited keyboard<br>shortcut support. | None | Yes, there is a difference. The<br>difference does not raise any<br>new potential safety risks and<br>therefore, there is no impact on<br>safety or efficacy for the subject<br>device. |
| 41 | Multi-Planar<br>Reconstruction<br>(MPR) | None | Yes, there is a Multi-<br>Planar Reconstruction<br>(MPR) feature. MRP is<br>a technique used in<br>two-dimensional<br>tomographic imaging<br>(computed tomography<br> | Yes, there is a difference. The<br>predicate device does not have<br>the MPR feature. The<br>difference has been reviewed<br>as part of the Hazard Analysis<br>and the mitigations were<br>tested. The difference does not<br>raise any new potential safety<br>risks and therefore, there is no<br>impact on safety or efficacy for<br>the subject device. |

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## 510(k) Summary

### Nonclinical Testing:

The ZED LINK™ , system and configuration has been assessed and tested at ZED Technologies PTY. LTD. and has passed all pre-determined testing criteria. The Verification & Validation Test Plan was designed to evaluate input functions, output functions, and actions performed by the ZED LINK™, software in each operational mode and followed the process documented in the Validation Test Plan.

Nonclinical testing results are provided in the 510(k). Validation testing indicated, that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met. If the device is installed by ZED Technologies, integration and installations verification tests are conducted against acceptance criteria prior to release to the client.

### Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for the ZED LINK™, contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device.

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# 510(k) Summary

The subject device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The subject and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The modification to the subject device does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.

Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

Therefore, the ZED LINK™, device is substantially equivalent to the predicate device.