MiPACS HTML5 Web Viewer

K212984 · Lead Technologies, Inc. · LLZ · Nov 12, 2021 · Radiology

Device Facts

• Record ID: K212984
• Device Name: MiPACS HTML5 Web Viewer
• Applicant: Lead Technologies, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 12, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

MiPACS HTML5 Web Viewer, is a software device, that enables Users to view and manipulate medical images. Patient images/studies can be accessed by Users locally within the system or across a wide-area network at distributed locations. The MIPACS HTML5 Web Viewer requires no installation on the client's behalf and is compatible with any HTML5compliant web browser (e.g. Google Chrome. Microsoft Internet Explorer 10, Microsoft Edge, Mozilla Firefox, MacOS). Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Mammographic images with lossy, compression and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA. MiPACS HTML5 Web Viewer, is not intended for diagnostic image review on mobile devices.

Device Story

MiPACS HTML5 Web Viewer is a server-based medical image management and processing system; enables physicians and trained professionals to access, view, and manipulate DICOM images (e.g., modalities, GSPS, KO, SR) via HTML5-compliant web browsers. System functions include image layout management, window/level adjustment, zoom, Hounsfield unit measurement, linear/angle measurements, series comparison, scout line display, MPR/MIP, stack mode, grayscale inversion, filters, rotation, key image selection, and DICOM/Windows printing. Operates as a web-based interface for PACS/RIS/HIS/EMR integration; supports remote access across wide-area networks. Does not replace physician judgment; requires trained operators. Benefits include efficient diagnostic workflow, remote access to patient studies, and centralized image management. Output is displayed on medical-grade monitors for clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including verification and validation of output functions and system performance against predetermined acceptance criteria. Compliance with DICOM (PS 3.1-3.20) and software life cycle (IEC 62304) standards was demonstrated.

Technological Characteristics

Web-based software architecture; server-side application; client-side HTML5 browser access. Supports DICOM (NEMA PS 3.1-3.20). Database: SQL Server. Security: User ID/password authentication, HIPAA-compliant logging. Hardware requirements: 8-core Xeon processor, 8GB RAM, 500GB disk. Software life cycle: IEC 62304:2006/A1:2016. Risk management: IEC 60812 (FMEA).

Indications for Use

Indicated for viewing and manipulating medical images by trained professionals. Applicable to all patient populations requiring radiological imaging. Contraindicated for primary diagnostic interpretation of mammographic images using lossy compression or digitized film screen images; not intended for diagnostic review on mobile devices.

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

• InstaRISPACS / InstaZFP / InstaMobi V5.0 (K182572)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

LEAD Technologies Inc. % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive McKINNEY TX 75071

November 12, 2021

Re: K212984

Trade/Device Name: MiPACS HTML5 Web Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: August 5, 2021 Received: September 17, 2021

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. 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/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K212984

Device Name MiPACS HTML5 Web Viewer

#### Indications for Use (Describe)

MiPACS HTML5 Web Viewer, is a software device, that enables Users to view and manipulate medical images. Patient images/studies can be accessed by Users locally within the system or across a wide-area network at distributed locations. The MIPACS HTML5 Web Viewer requires no installation on the client's behalf and is compatible with any HTML5compliant web browser (e.g. Google Chrome. Microsoft Internet Explorer 10, Microsoft Edge, Mozilla Firefox, MacOS). Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Mammographic images with lossy, compression and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.

MiPACS HTML5 Web Viewer, is not intended for diagnostic image review on mobile devices.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: line-through;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Medicor Imaging. The word "medicor" is in gray, with the word "imaging" in a smaller font below it. To the right of the word "medicor" is a blue triangle pointing downwards.

#### Submission number: K212984

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

#### I. SUBMITTER

Mr. William Little, FDA Project Manager Medicor Imaging, a division of LEAD Technologies Inc. 1927 S. Tryon Street, Suite 200 Charlotte, NC, 28203 Tel: [phone] x 760 Fax: [phone] Email: [e-mail]

Date Prepared: November 3, 2021

#### II. DEVICE

Name of Device: MiPACS HTML5 Web Viewer Regulation Name: Medical Image Management and Processing System Classification Name: system, image processing, radiological (21 CFR 892.2050) Requlatory Class: II Product Code: LLZ

#### III. PREDICATE DEVICES

The predicate device is: InstaRISPACS / InstaZFP / InstaMobi V5.0 (K182572), Class II, requlation number; 892.2050, product code LLZ.

#### IV. DEVICE DESCRIPTION

MiPACS HTML5 is a medical software with a Moderate level of concern.

MiPACS HTML5 Web Viewer uses web-based technology and a secure operating system. This means that virtually any computer at any location can use an Internet browser to access the device and RIS systems. Whether on-site or from another location, physicians and trained professionals can manage, edit, view and move diagnostic exams quickly and efficiently. As part of the MiPACS HTML5 Web Viewer support, Medicor Imaging, performs virtually all the system maintenance.

The MiPACS HTML5 Web Viewer is an implementation of an IHE (Integrating the Healthcare Enterprise) compliant Image Archive and Report Repository. This includes the capabilities:

- . To store and retrieve various kinds of DICOM Objects such as:
- -Images from multiple modalities,
- -Grayscale Presentation States [GSPS], which specifies the presentations of images as gray scaling, zoom, text and graphical annotations,
- -Key Objects [KO], which specifies a particular selection of images for a specified reason and with an attached note,
- -Structured Reports [SR].

The MiPACS HTML5 Web Viewer, is a server application. Its Web-based User Interface is intended for system configuration and monitoring by system administrators.

#### Key Feature List

- . Web-based technology for access from anywhere
- Integration with any modality, RIS, HIS or EMR, desktop Integration, and custom integration
- . Turnkey installations including all PACS professional services

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Image /page/4/Picture/0 description: The image shows the text "510(k) Summary" in bold, black font. The text is centered on a white background. The text appears to be a title or heading for a document or section.

Image /page/4/Picture/1 description: The image shows the logo for Medicor Imaging. The word "medicor" is in gray, with the word "imaging" in a smaller font below it. To the right of the word "medicor" is a blue triangle pointing downwards.

#### Submission number: K212984

- Off-site disaster recovery service ●
- . Automatic management reports
- . Detailed HIPAA log of PACS transactions
- Diagnostic viewer

The MiPACS HTML5 Web Viewer device does not intend to replace the skills and judgment of a qualified physician/radiologist and must be used only by people who are properly trained in the system's functions and capabilities.

The User must be aware of the accuracy and precision limitations of the data displayed, printed or exported from The MiPACS HTML5 Web Viewer. The quality of the data depends on the information received, user interaction, and the features in the display device and printer, among others.

Warning: When an app viewer is being used, the medical images are only for consultation; and must not be viewed for diagnostic purpose.

#### V. INDICATIONS FOR USE

The MiPACS HTML5 Web Viewer is a software device that enables Users to view and manipulate medical images. Patient images/studies can be accessed by Users locally within the system or across a wide-area network at distributed locations. The MiPACS HTML5 Web Viewer requires no installation on the client's behalf and is compatible with any HTML5compliant web browser (e.q., Google Chrome, Microsoft Internet Explorer 10, Microsoft Edge, Mozilla Firefox, MacOS). Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Mammographic images with lossy, compression and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA. The MiPACS HTML5 Web Viewer, is not intended for diagnostic image review on mobile devices.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The subject and predicate devices are both web-based viewers which are indicated for medical image management, review, and data distribution. Both systems have been developed to replace traditional film handling in radiology. The subject device and the predicate device are substantially equivalent in the areas of general function, application, and intended use.

Any differences between the subject and predicate devices have no negative impact on the device safety or efficacy and do not raise any new potential or increased safety risks and are equivalent in performance to existing legally marketed devices.

| Feature/Functions | Subject Device –<br>MiPACS HTML5 Web<br>Viewer | Predicate<br>InstaRISPACS/<br>InstaZFP/ InstaMobi<br>K182572 | |
|-------------------------------------------------|-------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| System | Indications for Use | Medical image management and processing system | Medical image management and processing system |
| | Processor | 8 core Xeon Processor (or more) | Core i7 / Quad Core Xeon |
| Feature/Functions | Subject Device –<br>MiPACS HTML5 Web<br>Viewer | Predicate<br>InstaRISPACS/<br>InstaZFP/InstaMobi<br>K182572 | |
| Workstation Client<br>Hardware<br>(recommended) | Operating System | Any Operating System<br>(Windows, MacOS, Linux,<br>Firefox) | Windows 8.1 (64 bit) |
| | Display | Medical Grade Monitor is<br>recommended. Resolution<br>depends on the modality<br>type. | Medical Grade Monitor is<br>recommended. Resolution<br>depends on the modality<br>type. |
| | RAM | Minimum 8GB RAM | Minimum 8GB RAM |
| | Hard Disk | 500 GB minimum | 750GB minimum |
| | Server features | System Architecture | Web based |
| Hardware | | Vendor Agnostic | Vendor Agnostic |
| Security | | Log-on user ID &<br>password | Log-on user ID &<br>password |
| Remote monitoring | | Yes | Yes |
| Database | | SQL Server | MySQLv5.7 |
| Viewer Features: | Image Viewing Layout | Customer Layout or Std.<br>formats (up to 4*4) | Std. formats (up to 4*4) |
| | WW/WL | Yes | Yes |
| | Zoom in/Zoom out | yes | yes |
| | Hounsfield<br>Measurement | Yes | Yes |
| | Linear and angle<br>measurements | Yes | Yes |
| | Series Comparison | Yes | Yes |
| | Scout line display | Yes | Yes |
| | MPR/MIP capabilities | Yes | Yes |
| | Stack mode | Yes | Yes |
| | Gray scale invert | Yes | Yes |
| | Filters | Yes | Yes |
| | Rotate | Yes | Yes |
| | Key Image selection | Yes | Yes |
| | DICOM Print | Yes | Yes |
| | Windows print | Yes | Yes |
| | Query/Retrieve | Yes | Yes |
| Image compression | Lossless streaming | Lossless streaming | |
| Feature/Functions | Subject Device –<br>MiPACS HTML5 Web<br>Viewer | Predicate<br>InstaRISPACS/<br>InstaZFP/ InstaMobi<br>K182572 | |
| Selection tools | Thumbnails | Thumbnails | |
| Other features | Link to Hospital<br>Information System<br>(HIS) | Yes | |
| | HIPAA | Compliant | |
| | PACS Server | Yes | |
| Configurations | Radiology Workstation | Yes | |
| | Basic Image Viewer | Yes | |

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Image /page/5/Picture/0 description: The image shows the Medicor Imaging logo. The word "medicor" is in gray, with the word "imaging" in a smaller font below it. A blue triangle is located above and to the right of the word "medicor."

# Submission number: K212984

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Image /page/6/Picture/0 description: The image shows the logo for Medicor Imaging. The word "medicor" is in gray, with the word "imaging" in a smaller font below it. To the right of the word "medicor" is a blue triangle pointing downwards, with a trademark symbol next to it.

#### Submission number: K212984

#### VII. PERFORMANCE DATA

Clinical testing is not necessary to show substantial equivalence for the subject device. Successful Bench Testing should be sufficient in demonstrating substantial equivalence.

#### Nonclinical Testing:

The MiPACS HTML5 Web Viewer has been assessed and tested at the company's facility and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate output functions, and actions performed by Medicor Imaging, 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.

#### Summary:

Based on the performance as documented in the Validation Testing, MiPACS HTML5 Web Viewer was found to have a safe and effectiveness profile that is similar to the predicate device.

The following Standards were used to develop the MiPACS HTML5 Web Viewer, and the device has met all the requirements listed in the Standards except for inapplicable requirements:

| Title of Standard | Date Of<br>Recognition | Specialty<br>Task<br>Group Area | FDA<br>Recognition<br>Number | Standard<br>Developing<br>Organization | Standard<br>Designation<br>Number and<br>Date |
|-----------------------------------------------------------------------------------------|------------------------|---------------------------------|------------------------------|----------------------------------------|-----------------------------------------------|
| Digital Imaging<br>and<br>Communications<br>in Medicine<br>(DICOM) Set | 06/27/2016 | Radiology | 12-300 | NEMA | PS 3.1 - 3.20<br>(2016) |
| Analysis<br>techniques for<br>system reliability -<br>Procedure for<br>failure mode and | 01/14/2019 | Radiology | 5-120 | IEC | 60812 Edition<br>3.0 2018-08, |

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Image /page/7/Picture/0 description: The image shows the logo for Medicor Imaging. The word "medicor" is written in gray, with the word "imaging" written in a smaller font size below it. To the right of the word "medicor" is a blue triangle pointing downwards, with a trademark symbol next to it. The logo is simple and professional, and it is likely used to represent the company's brand.

#### Submission number: K212984

| Title of Standard | Date Of<br>Recognition | Specialty<br>Task<br>Group Area | FDA<br>Recognition<br>Number | Standard<br>Developing<br>Organization | Standard<br>Designation<br>Number and<br>Date |
|----------------------------------------------------------------------------------------------------------|------------------------|---------------------------------|------------------------------|----------------------------------------|-----------------------------------------------|
| effects analysis<br>(FMEA) | | | | | |
| Medical device<br>software -<br>Software life cycle<br>processes<br>[Including<br>Amendment 1<br>(2016)] | 01/14/2019 | Software/<br>Informatics | 13-79 | ANSI AAMI<br>IEC | 62304:2006/A<br>1:2016 |

- . FDA Guidance on Cyber Security: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Document Issued on: October 2, 2014
- . FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005

#### VIII. CONCLUSIONS

The 510(k) Pre-Market Notification for the MiPACS HTML5 Web Viewer contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device and predicate device are substantially equivalent in the areas of technical characteristics, general function, and intended use. The MiPACS HTML5 Web Viewer do 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 comparably to the predicate devices.