(42 days)
Not Found
No
The document describes a standard PACS system for image management, archiving, retrieval, and display. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies sections. The focus is on workflow management, hard copy replacement, remote access, and electronic image integration.
No
The device is an image management system (PACS) that archives, retrieves, and displays medical images and data. It does not provide any treatment or therapy.
No
Explanation: The device is an image management system (PACS) whose intended use is to archive, retrieve, and display images. While it can display images for primary image diagnosis in mammography (if they are pre-processed DICOM for presentation and viewed on a compliant monitor), its primary function is not to perform a diagnosis itself but to manage and display images. It is explicitly stated that "ZED LINK™, is not intended for diagnostic image review on mobile devices." The device itself does not offer diagnostic capabilities but rather serves as a platform for professionals to review images for diagnosis.
Yes
The device description and intended use clearly define ZED LINK™ as a system for managing, archiving, retrieving, and displaying medical images and data. It functions as a hard copy replacement, provides remote access, acts as an electronic image integration platform, and manages radiology workflow. These functions are inherently software-based, dealing with digital data and its manipulation and presentation. There is no mention of any accompanying hardware components that are part of the device itself, only the modalities and systems it interfaces with and the monitors required for viewing. The testing described focuses on software verification and validation.
Based on the provided information, the ZED LINK™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that ZED LINK™ is an "image management system" for archiving, retrieving, and displaying medical images and data. While it facilitates the display of images for potential diagnostic interpretation (especially mammography), its primary function is managing the images themselves, not performing a diagnostic test on a biological sample.
- Device Description: The description focuses on functions like hard copy replacement, remote access, electronic image integration, and workflow management. These are all related to the handling and organization of medical images and information, not the analysis of biological specimens.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. ZED LINK™ does not interact with or analyze biological samples.
While the system is crucial for the workflow of diagnostic imaging and allows for the display of images that are used for diagnosis, the device itself is a PACS (Picture Archiving and Communication System) and image management tool, not an IVD. The diagnostic interpretation is performed by the healthcare professional viewing the images displayed by the system.
N/A
Intended Use / Indications for 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.
Product codes
LLZ
Device Description
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).
- Radiology Workflow Management: Used by radiology personnel to manage the workflow of patient exams.
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.
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, CT, DR, MR, and other devices
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this system are doctors and health care professionals.
Hospitals and related institutions and sites.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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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.
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 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,
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) 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 +61 1300 662 980 Email: ronald@zedtechnologies.com
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).
4
- . 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.
5
- . 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
| Functionality | Predicate: BOX DICOM
Viewer K151957 | Subject Device: ZED
LINKTM | If different, Impact on Safety
and or Efficacy |
|----------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Web Browser | Google Chrome for all
features.
Microsoft Internet | Our viewer supports
Microsoft Internet
Explorer, Microsoft | Yes, there are differences. The
difference is that the subject
device covers additional Web |
| Ref
| Functionality | Predicate: BOX DICOM
Viewer K151957 | Subject Device: ZED
LINK TM | If different, Impact on Safety
and or Efficacy |
| 1 | | Explorer &
Mozilla Firefox for
features except the
DICOM Viewer | Edge, Mozilla Firefox,
Google Chrome, Apple
Safari and Opera for
all features. | Browsers and they can be used
for all device features. |
| 2 | Intended use | Acquiring, viewing,
editing and storing
radiographs and related
patient's images | Same as predicate | No difference |
| 3 | Intended user | Radiologist & qualified
medical personnel | Same as predicate | No difference |
| 4 | Network | 10/100/100 Ethernet | Same as predicate | No difference |
| 5 | Monitor | Above 19inch monitor
(Using 1280x1024) | Same as predicate | No difference |
| 6 | User
interaction/input | Same, Using 1280x1024 | Same as predicate | No difference |
| 7 | Import / export
images | Yes | Same as predicate | No difference |
| 8 | Acquisition
devices | CT, MR, US, PET | Same as predicate | No difference |
| 9 | Image
organization | Patient ID, Name, study
instance UID | Same as predicate | No difference |
| 10 | Image search
available | Same | Same as predicate | No difference |
| 11 | Image storage | Yes | Same as predicate | No difference |
| 12 | Database
software | MySQL | MS SQL | No difference |
| 13 | Greyscale
Image
Rendering | Yes | Same as predicate | No difference |
| 14 | RGB Image
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
Markers | Yes | Same as predicate | No difference |
| 18 | Distance
Markers | Yes | Same as predicate | No difference |
| Ref
| Functionality | Predicate: BOX DICOM
Viewer K151957 | Subject Device: ZED
LINK TM | If different, Impact on Safety
and or Efficacy |
| 19 | Study Data
Overlays | Yes | Same as predicate | No difference |
| 20 | Stack
Navigation | Yes | Same as predicate | No difference |
| 21 | Window Level | Yes | Same as predicate | No difference |
| 22 | Zoom in on
images | Yes | Same as predicate | No difference |
| 23 | Panning | Yes | Same as predicate | No difference |
| 24 | Horizontal/Vertic
al Flip | Yes | Same as predicate | No difference |
| 25 | Clockwise/Coun
terclockwise
rotate | Yes | No | Yes, there is a difference. The
difference does not raise any
new potential safety risks and
therefore, there is no impact on
safety or efficacy for the
subject device. |
| 26 | Invert image | Yes | Same as predicate | No difference |
| 27 | Text Annotation | Yes | Same as predicate | No difference |
| 28 | Area
measurement
annotation | Yes | No | Yes, there is a difference. The
difference does not raise any
new potential safety risks and
therefore, there is no impact on
safety or efficacy for the subject
device. |
| 29 | Angle
measurement
annotation | Yes | Same as predicate | No difference |
| 30 | Cobb Angle
Measurement
Annotation | Yes | Same as predicate | No difference |
| 31 | Image
annotation | Yes | Same as predicate | No difference |
| 32 | Security | Yes | Same as predicate | No difference |
| 33 | DICOM 3.0
conformance | Yes | Same as predicate | No difference |
| 34 | Worklist | Yes | Same as predicate | No difference |
| Ref
| Functionality | Predicate: BOX DICOM
Viewer K151957 | Subject Device: ZED
LINK TM | If different, Impact on Safety
and or Efficacy |
| 35 | Thumbnail
viewing | Yes, thumbnails on
preview, small, medium
and large | Same as predicate | No difference |
| 36 | Login | Yes | Same as predicate | No difference |
| 37 | Audit | Yes, a tool to view
access logs in real time. | Same as predicate | No difference |
| 38 | WebGL
rendering
optimizations | No hardware
acceleration. | Same as predicate | No difference |
| 39 | Support for high
resolution
Retina displays | Pixelated display on
high-DPI displays only
(i.e., "Retina Displays"). | Same as predicate | No difference |
| 40 | Keyboard
shortcuts for
tools and all
annotation types | Limited keyboard
shortcut support. | None | Yes, there is a difference. The
difference does not raise any
new potential safety risks and
therefore, there is no impact on
safety or efficacy for the subject
device. |
| 41 | Multi-Planar
Reconstruction
(MPR) | None | Yes, there is a Multi-
Planar Reconstruction
(MPR) feature. MRP is
a technique used in
two-dimensional
tomographic imaging
(computed tomography
| Yes, there is a difference. The
predicate device does not have
the MPR feature. The
difference has been reviewed
as part of the Hazard Analysis
and the mitigations were
tested. The difference does not
raise any new potential safety
risks and therefore, there is no
impact on safety or efficacy for
the subject device. |
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7
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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.