Lightning Viewer is software for diagnostic and clinical review intended for use in General Radiology (images from modalities including CR/DR/XT, CT, FL, MR, MG, NM, US/US Echo, PET, VL) and other healthcare imaging applications.

Lightning Viewer is intended to be used with off the shelf computing devices. Display monitors used for reading medical images for diagnostic purposes must comply with applicable clinical requirements, requlatory approvals, and with quality control requirements for their use and maintenance. With appropriate display monitors, lighting, image quality, and level of lossy image compression, Lightning Viewer is intended for diagnostic purposes to be used by trained healthcare professionals. Display calibration and lighting conditions should be verified by viewing a test pattern prior to use for diagnostic purposes.

Lightning Viewer supports major desktop browsers such as Microsoft Edge, Chrome, Safari, and Windows. Lightning Viewer displays both lossless and lossy compressed images. Each healthcare professional must ensure that they have the necessary environment to ensure the appropriate image quality for their clinical purpose and determine the level of lossy image compression acceptable for their purpose. Lossy image compression should not be used for primary reading in mammography.

Lightning Viewer can be utilized for image manipulation by radiology technologists or other healthcare professionals. Lightning Viewer can be used to verify that images captured in a medical imaging system have a diagnostic quality: to correct viewing characteristics of the image such as orientation, rotation, and contrast; as well as to add annotations to mark significant findings or provide guidance for radiologists.

Lightning Viewer can store annotations and measurements as DICOM presentation states without changing the original image data. Lightning Viewer can display annotations and measurements as an overlay on images from DICOM objects, and from Computer-Aided Diagnosis (CAD) and AI software. The viewer can perform 3D Multi-Planar Reformatting (MPR), 3D Maximum Intensity Projection (MIP) and 3D Volume Rendering (VR). Lightning Viewer is purposed to aid in reviewing findings through its ability to display clinical documents and reports side by side with the images. This can be used side by side with a reporting tool to create diagnostic reports.

Device Description

Lightning Viewer is a web-based DICOM medical image viewer that allows for diagnostic viewing, measuring, manipulating, and annotation of radiological series and images. The Lightning Viewer is part of a server, providing healthcare professionals with a comprehensive tool for accessing and interacting with medical images. Key features and functions of the Medweb Lightning Viewer include:

A web browser-based interface for easy access without client software installation ●
Support for multiple imaging modalities including CR/DR/XR, CT, MR, US/US Echo, MG (Mammo), FL (Fluoro), VL (visual light), NM (Nuclear medicine), PET
. Advanced image manipulation tools such as window/level adjustment, zooming, panning, and image rotation
. Measurement and annotation capabilities including length, angle, area, and freehand ROI tools
Specialized tools for specific imaging modalities, such as for mammography tools and spine labeling
. MPR (Multiplanar Reconstruction) mode with crosshairs tool for 3D visualization and MIP (Maximum Intensity Projection)
. Synchronized scrolling across series and studies for efficient comparison
Customizable layouts and hanging protocols for various study types
DICOM-compliant image viewing and data management .

The Medweb Lightning Viewer consists of a user-friendly workspace with a customizable toolbar, providing quick access to commonly used tools. The viewer supports various layout options, including side-by-side comparison of series and prior studies. Users can easily navigate through image stacks, adjust window/level settings, and apply advanced visualization techniques like MPR.

Medweb Lightning Viewer is designed to integrate seamlessly with existing PACS installations. It allows authorized users to access patient studies from multiple sources, facilitating efficient workflow for radiologists, physicians, and other healthcare professionals.

Lightning Viewer provides a comprehensive set of tools for image review and analysis. It supports various image formats and modalities, making it a versatile solution for healthcare facilities of all sizes.

The system employs user authentication and access controls to ensure that only authorized personnel can access sensitive patient information. This makes it suitable for use both within healthcare facilities and for remote access by referring physicians or specialists, promoting efficient telemedicine and teleradiology practices.

AI/ML Overview

The provided document, a 510(k) Summary for the Lightning Viewer, describes the device's acceptance criteria and the study that proves it meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the Lightning Viewer's performance was evaluated through "Software Verification and Validation Testing" and "Non-Clinical Performance Testing". The acceptance criteria are implicitly that the device performs equivalently to the predicate device and accurately calculates measurements.

Acceptance Criterion	Reported Device Performance
Software Functionality & Performance	Verified that design requirements were successfully met and intended use/user needs were validated. Device performs in an equivalent manner to the predicate device (OmegaAI Image Viewer).
Measurement Accuracy	Phantom study demonstrated that the device accurately calculates distance and angle measurements based on user-defined inputs.
Safety & Effectiveness (comparative)	No differences between Lightning Viewer and predicate device (OmegaAI Image Viewer) raise new questions of safety and effectiveness.

2. Sample Size for the Test Set and Data Provenance:

Sample Size for Test Set: Not explicitly stated for either the software verification/validation or the phantom study. The document only mentions "a dataset with known voxel dimensions" for the phantom study.
Data Provenance: Not explicitly stated. Given the nature of the tests (software verification/validation, phantom study), the data would likely be internally generated and controlled rather than from external patient sources or specific countries. It's a non-clinical evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Number of Experts: Not specified.
Qualifications of Experts: Not specified. For a phantom study, ground truth is typically established by the known physical properties of the phantom and the measurements taken from it, rather than expert interpretation. For software verification/validation, ground truth is typically against predefined functional specifications and requirements.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable or not specified. Given the nature of the studies (software verification/validation and phantom study), expert adjudication in the medical sense (e.g., 2+1, 3+1 for clinical endpoints) is not described. Ground truth for these types of studies is usually based on predefined specifications or known physical properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

MRMC Study: No, an MRMC comparative effectiveness study was not done.
Effect Size: Not applicable as no MRMC study was performed. The device is a medical image management and processing system, not an AI-assisted diagnostic tool for human readers in the context of improving their performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The document implies that standalone performance was assessed for measurement accuracy in the phantom study. The "device accurately calculates distance and angle measurements" without mention of human intervention in the calculation process. However, the primary purpose of the device is a viewer that facilitates human review, not an autonomous diagnostic algorithm. The software verification and validation would also evaluate the standalone functionality of the viewer.

7. The Type of Ground Truth Used:

Software Verification and Validation: Ground truth was established against predefined "design requirements" and "intended use and user needs." This implies a set of functional and performance specifications.
Non-Clinical Performance Testing (Phantom Study): Ground truth was established by a "dataset with known voxel dimensions" which allows for precise calculation of true distances and angles against which the device's measurements are compared.

8. The Sample Size for the Training Set:

Training Set Sample Size: Not applicable. The Lightning Viewer is a DICOM viewer and image manipulation system, not a machine learning or AI-driven diagnostic algorithm that requires a training set in the conventional sense. Its functionality is based on established image processing algorithms and display standards.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth for Training Set: Not applicable, as there is no mention of a training set for machine learning.

Summary

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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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Nexsys Electronics Inc. dba Medweb % Dr. Yujan Shrestha CEO Innolitics 1101 West 34th St #550 Austin, Texas 78705

December 20, 2024

Re: K242362

Trade/Device Name: Lightning Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: November 21, 2024 Received: November 21, 2024

Dear Dr. Yujan Shrestha:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Lamb

Jessica Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K242362

Device Name

Lightning Viewer

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image contains the logo for Innolitics. The logo consists of a blue hexagon-like shape on the left and the word "Innolitics" in blue on the right. The hexagon shape is made up of six triangular shapes that are arranged to form a hexagon.

1. CONTACT INFORMATION

Company Name	Nexsys Electronics Inc. dba Medweb
Address	800 Airport Blvd Suite 318, Burlingame, CA 94010
Phone Number	415-541-9980
Company Representative	Brian Bandy, Director of Software Development, Medweb
Email	bbandy@medweb.com
Primary Correspondent	Yujan Shrestha, CEO, Innolitics
Primary Correspondent Email	fda@innolitics.com
Date Summary Prepared	August 8th, 2024

2. DEVICE INFORMATION

Item	Description
Device Name	Lightning Viewer
Manufacturer	Nexsys Electronics Inc. dba Medweb
Product Code	LLZ
Regulation Number	892.2050
Regulation Name	System, Image Processing, Radiological
Regulatory Class	Class II
Review Panel	Radiology

3. PREDICATE DEVICE INFORMATION

Item	Description
Device Name	OmegaAI Image Viewer
Manufacturer	RamSoft Inc.

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Image /page/5/Picture/0 description: The image shows the logo for Innolitics. The logo consists of a blue hexagon-like shape on the left and the word "Innolitics" in blue on the right. The hexagon shape is made up of six triangular pieces that are arranged to form a hexagon with a white space in the center.

Effective Date: 2024-12-20

Page 2 of 7

Item	Description
510(k) Number	K222476
Product Code	LLZ
Regulation Number	892.2050
Regulation Name	System, Image Processing, Radiological
Regulatory Class	Class II
Review Panel	Radiology

4. DEVICE DESCRIPTION

A web browser-based interface for easy access without client software installation ●
Support for multiple imaging modalities including CR/DR/XR, CT, MR, US/US Echo, MG (Mammo), FL (Fluoro), VL (visual light), NM (Nuclear medicine), PET
. Advanced image manipulation tools such as window/level adjustment, zooming, panning, and image rotation
. Measurement and annotation capabilities including length, angle, area, and freehand ROI tools
Specialized tools for specific imaging modalities, such as for mammography tools and spine labeling
. MPR (Multiplanar Reconstruction) mode with crosshairs tool for 3D visualization and MIP (Maximum Intensity Projection)
. Synchronized scrolling across series and studies for efficient comparison
Customizable layouts and hanging protocols for various study types
DICOM-compliant image viewing and data management .

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Image /page/6/Picture/0 description: The image shows the logo for Innolitics. The logo consists of a blue hexagon-like shape on the left and the word "Innolitics" in blue on the right. The hexagon shape is made up of several triangular pieces that are arranged to form the hexagon.

through image stacks, adjust window/level settings, and apply advanced visualization techniques like MPR.

Effective Date: 2024-12-20

4.1. Key Marketing Claims

Lightning Viewer is a zero-footprint web viewer for medical images, offering fast and efficient access to patient studies. It provides a comprehensive toolset for image manipulation and analysis in a user-friendly interface. Medweb's Lightning Viewer supports DICOM-compliant images and integrates seamlessly with existing PACS.

5. INTENDED USE

The intended use of Medweb Lightning Viewer is to review and navigate diagnostic images. The viewer includes tools to aid in visualizing a region of interest.

6. INDICATIONS FOR USE

Lightning Viewer is intended to be used with off the shelf computing devices. Display monitors used for reading medical images for diagnostic purposes must comply with applicable clinical requirements, regulatory approvals, and with quality control requirements for their use and maintenance. With appropriate display monitors, lighting, image quality, and level of lossv image compression, Lightning Viewer is intended for diagnostic purposes to be used by trained healthcare professionals. Display calibration and lighting conditions should be verified by viewing a test pattern prior to use for diagnostic purposes.

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Image /page/7/Picture/0 description: The image shows the logo for Innolitics. The logo consists of a blue hexagon-like shape on the left and the word "Innolitics" in blue on the right. The hexagon shape is made up of six overlapping, curved shapes that create a sense of depth and movement. The word "Innolitics" is written in a bold, sans-serif font.

Effective Date: 2024-12-20

Lightning Viewer can be utilized for image manipulation by radiology technologists or other healthcare professionals. Lightning Viewer can be used to verify that images captured in a medical imaging system have a diagnostic quality; to correct viewing characteristics of the image such as orientation, rotation, and contrast; as well as to add annotations to mark significant findings or provide guidance for radiologists.

7. CONTRAINDICATIONS FOR USE

Lightning Viewer is contraindicated for the following:

For use on monitors that do not meet technical specifications required for radiographic 1. image review, including 5 mega-pixel resolution.
Lossy image compression must not be used for primary reading in mammography. 2.

8. SUBSTANTIAL EQUIVALENCE SUMMARY

Lightning Viewer is similar to the predicate device in the following ways:

. Intended use: Both devices are intended for diagnostic purposes and to be used as a review tool.
Indications for use: Both devices have similar indications for use as SaMD for . diagnostic review in radiology and healthcare imaging.
. Technology characteristics: Both devices have similar core capabilities in image manipulation, 3D imaging, and AI/CAD annotation display across major desktop browsers and various imaging modalities.

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Image /page/8/Picture/0 description: The image contains the logo for Innolitics. The logo consists of a geometric shape on the left and the word "Innolitics" on the right. The geometric shape is a hexagon made up of six overlapping triangles. The word "Innolitics" is written in a sans-serif font and is in blue.

. Safety: Both devices SaMD/viewer systems, and don't pose any direct safety hazard to the patient.
Effective Date: 2024-12-20
Performance Testing: As both devices are SaMD/viewer systems, both were subjected ● to similar verification and validation testing.
See Device Comparison Table below for details.

8.1. Indications for Use Comparison

Lightning Viewer and the predicate device have similar indications for use. Both devices are software solutions for diagnostic and clinical review in general radiology and other healthcare imaging applications. They support major desktop browsers and various imaging modalities. allowing for image manipulation, 3D imaging, and AI/CAD annotation display. While the predicate offers broader functionality across more specialties and mobile platforms, these differences do not raise new questions of safety or effectiveness. The core diagnostic capabilities, image quality considerations, and emphasis on appropriate display conditions remain consistent between both viewers. The absence of mobile functionality or extended specialties in Lightning Viewer's indications does not impact its safety or effectiveness within its intended use scope.

Feature	Lightning Viewer	OmegaAI Image Viewer	Comments
Intended Use	Lightning Viewer isintended for diagnosticpurposes and to be usedas a review tool.	The OmegaAI Image Vieweris intended for diagnosticpurposes and to be used as areview tool.	Same
MammographicUse	Lossy imagecompression should notbe used for primaryreading inmammography.	Lossy imagecompression should not beused for primary reading inmammography.	Same
ImageManipulationFeatures	Adjustment Tools:Window level, rotate,flip, pan, stack scroll, andzoom.Markup Tools:Annotate, angle, cobbangle, probe, Mark ROI,and measurement.	Adjustment Tools:Window level, rotate, flip,pan, stack scroll, and zoom.Markup Tools:Annotate, angle, cobb angle,probe, Mark ROI, andmeasurement.	Same
Feature	Lightning Viewer	OmegaAI Image Viewer	Comments
SpecializedTools	Spine labeling:Mammography tools	Unknown.	The subject device has specialized tools forspecific use cases, such as spine labelingand mammography tools. These tools fallunder the same general intended use toreview and navigate diagnostic images andaiding users in visualizing a region ofinterest. Thus, the inclusion of thesespecialized tools do not raise any newquestions of safety and effectiveness.
SupportModalities	Supports the followingimage modalitiesCR/DR/XR, CT, FL, MR,MG, NM, US/US Echo,PET and VL.	View all image modalities,including CR, CT, DX, MR,MG, NM, US, PET, RG, SC,VL, XA, PET, and FilmDigitizer.	Both devices support a wide range of imagemodalities, including CR, CT, MR, MG,NM, US, PET, and VL. The predicatedevice supports additional modalities likeDX, RG, SC, XA, and Film Digitizer. Thisdifference does not raise any new questionsof safety or effectiveness. The additionalmodalities supported by the predicate devicedo not impact the safety or effectiveness ofLightning Viewer for its intended use cases.
Architecture	A web-based softwaresolution that displaysimages and reports from aPACS through a zero-footprint applicationaccessible via a webbrowser, requiring noinstallation.	Server-based softwaresolution that displays imagesand reports from a PACSusing a zero-footprintapplication (browser).No installation is needed.	Both devices are zero-footprint and requireno installation. The subject device is web-based, while the predicate device is server-based. The architectural difference does notimpact the core functionality, safety, oreffectiveness of either device. Botharchitectures are commonly used in medicalimaging and have established safety andperformance profiles.
Technology	Use of varioustechnology standards likeDICOM, DICOMweb,WADO, Rest, HL7.	Use of various technologystandards (LDAP, SSO,HTTPS, HTML, HL-7Integration web services,etc.)	Both devices utilize industry-standardtechnologies for communication and dataexchange (DICOM, HL7). Each device usesa different set of additional technologies tosupport its architecture and features (e.g.,web-based vs. server-based). Thesedifferences do not impact the safety oreffectiveness of the devices. The differenttechnologies used by the devices are allindustry-standard and well-established fortheir respective purposes (security,communication, data exchange).
SupportPlatforms,Devices	Supports major browserslike Chrome and Safari.	Supports major desktop (fordiagnostic purposes) andmobile platforms (for non-diagnostic purposes; can beused as a review tool) such asMicrosoft Edge, Chrome,	The predicate device supports a wider rangeof platforms, including desktop and mobileoperating systems. Lightning Viewer isdesigned as a web-based application andrelies on the browser's capabilities forcompatibility and rendering. This difference
Feature	Lightning Viewer	OmegaAI Image Viewer	Comments
		Safari, Apple iOS, Android,Windows and Mac devices.	does not raise new questions of safety oreffectiveness.

8.2. Device Comparison Table

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510(k) Summary

DOC-0031 Rev C

Effective Date: 2024-12-20

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9. PERFORMANCE DATA

9.1. Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by 2023 FDA Guidance "Content of Premarket Submissions for Device Software Functions".

The software verification and validation testing verified that the design requirements were successfully met. The intended use and user needs were successfully validated.

As the intended use, functionality and performance of the subject device and the predicate device are equivalent, the result of the performance testing is evidence that the Lightning Viewer performs in an equivalent manner to the OmegaAI Image Viewer.

9.2. Non-Clinical Performance Testing

A phantom study using a dataset with known voxel dimensions to evaluate the accuracy of the device's measurement calculations was performed and demonstrated that the device accurately calculates distance and angle measurements based on user-defined inputs.

9.3. Clinical Performance Testing

No clinical performance data was necessary to claim substantial equivalence.

10. CONCLUSION

The Lightning Viewer shares similar technological characteristics, intended use, and functionality with the predicate device. There are no differences between the devices that raise new questions of safety and effectiveness.

Furthermore, non-clinical performance test data and software verification and validation demonstrate that Lightning Viewer performs comparably to the predicate device in terms of safety and effectiveness.

Based on the device comparisons and the acceptable testing results, it is determined that Lightning Viewer is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).