Omni-Vue 2™ System is a software device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Device options make possible reading (including mammography), telecommunications; fast demonstration; etc .; and teleconferencing.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by FDA

Device Description

Omni-Vue 2™ System makes possible the capturing, storage, distribution, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available, the System can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation.

AI/ML Overview

The provided K130374 510(k) summary for the Omni-Vue 2™ System details the device's characteristics and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, a detailed study proving the device meets these criteria, or information regarding sample sizes for test/training sets, ground truth establishment, or expert involvement as requested.

The document primarily focuses on establishing substantial equivalence by comparing the features of the Omni-Vue 2™ System to its predicate device, OmniVue, and demonstrating that any differences do not impact safety or efficacy. The "Nonclinical Testing" section mentions that "predetermined acceptance criteria were met" but does not specify what those criteria were or detail the studies performed to meet them.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text, with explicit notes where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated in the document)	Reported Device Performance (Implied from substantial equivalence claim)
Functionality equivalent to predicate device	Omni-Vue 2™ provides core PACS functionalities (DICOM Storage SCU/SCP, Q/R SCU/SCP, image manipulation, reporting, etc.)
Safety equivalent to predicate device	"The modification to the subject device does not raise any new potential safety risks."
Efficacy equivalent to predicate device	"The new device does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices."
Predetermined acceptance criteria for internal testing (details not provided)	"The complete system configuration has been assessed and tested at the factory and has passed all in-house testing criteria. ... Validation testing indicated that ... the predetermined acceptance criteria were met."

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

Sample Size: Not specified. The document mentions "nonclinical testing results" but does not provide details on the number of images or cases used in the testing.
Data Provenance: Not specified. It doesn't mention country of origin or whether the data was retrospective or prospective.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document generally states that "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed," but this refers to the intended use of the device, not the ground truth establishment for testing.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

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

No MRMC comparative effectiveness study is mentioned. This device is a PACS system, not an AI-assisted diagnostic tool, so such a study would not be applicable in this context.

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

No standalone performance study is mentioned or applicable, as this is a software system intended for human interaction and interpretation.

7. The Type of Ground Truth Used

Not specified. The document refers to "nonclinical testing results" and meeting "predetermined acceptance criteria" but does not elaborate on the nature of the ground truth used for these internal tests.

8. The Sample Size for the Training Set

Not applicable. This document describes a Picture Archiving Communications System (PACS), which is a software device for managing and viewing medical images. It does not involve a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

K130374
Page 1 of 5

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

Date Prepared:

August 25, 2013

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

Mr. Alain Tabares, Chief Technical Officer Genesis Digital Imaging, Inc. 12921 W. Washington Blvd. Los Angeles. CA 90066

AUG 29 2013

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

Trade Name:	Omni-Vue 2™ System
Common Name:	Picture Archiving Communications System
Device Classification:	892.2050
Name:	System, Image Processing

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

Device Classification Name	system, image processing, radiological20
510(K) Number	K073062
Device Name	OMNI-VUE SYSTEM
Applicant	GENESIS DIGITAL IMAGING, INC.
Regulation Number	892.2050
Classification Product Code	LLZ
Date Received	10/30/2007
Decision Date	03/10/2008
Decision	substantially equivalent (SE)
Classification Advisory Committee	Radiology
Review Advisory Committee	Radiology
Type	Traditional

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

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

{1}------------------------------------------------

images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by FDA.

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

Omni-Vue 2™ System is a software product that handles and manipulates digital medical 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. OmniVue 2 is downsized product of OmniVue related with number of feature, however, OmniVue 2 improves data transfer security, and productivity and brevity of PACS configuration. The reason for data transfer security is improved, is due to FTPS(File Transfer Protocol SSL) and ODBC(Open Database Connectivity) on SSL. Another reason for brevity of PACS configuration is improved, is due to the fact that OmniVue 2 client application provides simple way to get image from CR, DR and digitizer.

The modified 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.

Any difference between the two devices does not affect safety or efficacy. The predicate device and the new device are compared below:

Item	OmniVue 2	OmniVuePredicate	Description
Login	Yes	Yes	For security purpose, login function is recommended.
Patient's list	Yes	Yes	Easy way to find the patient
DICOM Storage SCU	Yes	Yes	Routing to another workstation
DICOM Storage SCP	Yes	Yes	Getting images from other workstation
DICOM Q/R SCU	Yes	Yes	Requests patient from PACS server.
DICOM Q/R SCP	Yes	Yes	Response for patient exam request. Neo module has thisfunction.
DICOM Print Management	No	Yes	Film printing feature has been removed from the modifieddevice.Difference between the predicate and modified device, but hasno impact on safety or efficacy of the modified device anddoes not raise any new potential safety risks
Open DICOM Dir CD	No	Yes	The feature to open patient's CD from other PACS devices hasbeen removed from the modified device.Difference has no impact on safety or efficacy of the modifieddevice and does not raise any new potential safety risks
Burn patient's CD	Yes	Yes
CR interface: Direct importing	Yes	Yes	CR: Carestream Vita interface
Film digitizer interface	Yes	Yes	Vidar film digitizer interface
Multi film scanning	Yes	Yes	Multi films at one time.
Manual image import	Yes	Yes	Importing image one by one.
Batch import	Yes	Yes	Importing multiple images in a certain folder.
Non-DICOM file open andimport	No	Yes	The feature to open and import a non-DICOM file such asbmp, jpg and tiff and convert into DICOM format has beenremoved.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks
Paper printing	No	Yes	The feature to print a DICOM image to a paper printer hasbeen removed.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safety
Item	OmniVue 2	OmniVue Predicate	Description
			risks
Twain interface	No	Yes	The Interface with twain device feature used to scan imagesand other items has been removed.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks
Auto close	No	Yes	The auto feature to close current exam whenever a new examis opened has been removed.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks
Chest CT View	No	Yes	The feature to compare images at the same time withdifference Window Width/Level has been removed in themodified device.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks
Image layout change	Yes	Yes	Change layout by user's demand.
Series layout change	Yes	Yes	Change series layout by user's demand.
Image manipulation tools- W/L- Rotation- Flipping- Zoom in/out- Magnify glass- Auto W/L- Reset modification- Invert	Yes	Yes	Basic tools to manipulate images
DICOM header view	Yes	Yes	DICOM header dump for administrator
Cine view	No	Yes	The feature for Cine View for a slide show for images hasbeen removed.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks.
Hounsfield unit	No	Yes	The feature for using CT exam Hounsfield unit has beenremoved.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks
Scout line	No	Yes	The scout line feature for CT and MR has been removed. Thedifference has no impact on safety or efficacy of the modifieddevice and does not raise any new potential safety risks
Close and Open	Yes	Yes	Close current exam open next exam
W/L preset	No	Yes	The Window/Level preset database feature has beenremoved.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks
Sharpen preset	No	Yes	The sharpen preset database has feature been removed.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks
Look-Up Table preset	Yes	Yes	Use gamma value for image processing
Hanging protocol	No	Yes	The limited hanging protocol feature has been removed.The difference has no impact on safety or efficacy of the modified deviceand does not raise any new potential safety risks
Hanging protocol preset	No	Yes	The preset for layouts feature has been removed frommodified device.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks
Item	OmniVue 2	OmniVuePredicate	Description
Thumbnail view	Yes	Yes	Thumbnail image for exam
Chiropractic toolsCobb's angleCenter massAtlas plane lineNew Cobb's angleExtended Cobb's angleHorizontal deflectionChiro ratioMeasure from horizontalline	No	Yes	Specially designed tools for chiropractors has been removedfrom modified device.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks
Arbitrary rotation	No	Yes	The rotate image with arbitrary angle feature has beenremoved.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks
W/L for ROI only	No	Yes	The Window/Level feature in the ROI (region of interest) onlyhas been removed.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks
ROI	Yes	Yes	Region of Interest (ROI)
Measuring toolsRulerAngle	Yes	Yes	Measure angle or length
Customizing DICOM overlay	No	Yes	The feature to insert a customized DICOM overlay on theimage has been removed. The difference t has no impact onsafety or efficacy of the modified device and does not raiseany new potential safety risks.
External program interface	Yes	Yes	Launch external program
Customizing toolbar set	No	Yes	The feature to customize toolbar icons has been removed.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks.
Customizing worklist layout	Yes	Yes	Worklist layout change and column order change
Email with attachment	No	Yes	The feature to email an image file has been removed.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks.
Old exam list	Yes	Yes	List up old exam for the patient
Reporting	Yes	Yes	Create diagnostic report by radiologist
L/R mark on image	No	Yes	The feature to mark left/right image is removed because thefunction resides in a different module that indicatesL/R Mark on Image. This feature was a duplicate.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks.
Masking	No	Yes	The feature to mask image pixel if the pixel value is same withcertain color has been removed.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks.
Image stitching	No	Yes	The feature to stitch multiple images to one has been removedThe difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks.
Annotation	Yes	Yes	Write text on the image
All series mode	Yes	Yes	Set multiple series as one series
Item	OmniVue 2	OmniVuePredicate	Description
DICOM information edit	Yes	Yes	Other module has it.Only technician can modify DICOM information when theymade mistake.
Arrow lines	Yes	Yes	Draw arrow lines
Overlay show/hide	Yes	Yes
Display original size image	No	Yes	The feature to display the image by real body size has beenremoved.The difference has no impact on safety or efficacy of themodified device and does not raise any new potential safetyrisks.

{2}------------------------------------------------

. . . . .

{3}------------------------------------------------

{4}------------------------------------------------

K130374
Page 5 of 5

Nonclinical Testing:

The complete system configuration has been assessed and tested at the factory and has passed all in-house testing criteria. The Verification Test Plan was designed to evaluate all input functions, output functions, and actions performed by the Omni-Vue 2™ 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 Genesis Digital Imaging, Inc., 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 Omni-Vue 2™ contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device.

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, Omni-Vue 2™ is substantially equivalent to the predicate devices.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an eagle or bird with three curved lines representing its wings or feathers. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 29, 2013

Genesis Digital Imaging, Inc. % Mr. Carl Alletto Consultant OTech, Inc. 1600 Manchester Way CORINTH TX 76210

Re: K130374

Trade/Device Name: Omni-Vuc 2™ System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 1, 2013 Received: August 13, 2013

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 commence 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 cither class II (Special Controls) or class III (PMA), it your do roo is enabilional 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 (2 l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{6}------------------------------------------------

Page 2-Mr. Alletto

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/Medicall.cevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Reportal/roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications for Use

510(k) Number (if known): K130374

Device Name: Omni-Vue 2TM

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpari C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Sinh for	)
----------	---

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K130374 _______________________________________________________________________________________________________________________________________________________________

Page 1 of 1

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).