(196 days)
Not Found
No
The document describes a standard medical image management and viewing system (PACS-like functionality) and does not mention any AI or ML capabilities. The focus is on image acquisition, storage, distribution, and display.
No
The description indicates the device is a software system for image and data management, storage, and display, not for therapeutic intervention.
No
The device is a software system for image management, storage, communication, and display. While it handles medical images, its primary functions are related to data management rather than generating diagnostic interpretations or measurements itself. It facilitates the viewing and processing of images that may be used for diagnosis, but it does not perform the diagnostic function. The "Intended Use" states it "receives digital images and data" and that "Images and data can be stored, communicated, processed and displayed," which are functions of an image management system. It also explicitly states that "Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation," further indicating it's not for direct diagnostic interpretation.
Yes
The device is explicitly described as a "software device" in the Intended Use/Indications for Use section and the Device Description focuses solely on software functionalities for image handling and networking. While it interacts with hardware (imaging sources, workstations), the device itself is presented as the software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Omni-Vue 2™ System is described as a software device that receives, stores, communicates, processes, and displays medical images from various imaging modalities (CT, MR, ultrasound, etc.). Its primary function is image management and viewing for diagnostic interpretation by a physician.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples. The input is digital image data, not biological specimens.
Therefore, the Omni-Vue 2™ System falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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)
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.
Indications for Use: 21 CFR 807 92(a){5)
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
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 | OmniVue
Predicate | 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 this
function. |
| DICOM Print Management | No | Yes | Film printing feature has been removed from the modified
device.
Difference between the predicate and modified device, but has
no impact on safety or efficacy of the modified device and
does not raise any new potential safety risks |
| Open DICOM Dir CD | No | Yes | The feature to open patient's CD from other PACS devices has
been removed from the modified device.
Difference has no impact on safety or efficacy of the modified
device 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 and
import | No | Yes | The feature to open and import a non-DICOM file such as
bmp, jpg and tiff and convert into DICOM format has been
removed.
The difference has no impact on safety or efficacy of the
modified device and does not raise any new potential safety
risks |
| Paper printing | No | Yes | The feature to print a DICOM image to a paper printer has
been removed.
The difference has no impact on safety or efficacy of the
modified 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 images
and other items has been removed.
The difference has no impact on safety or efficacy of the
modified device and does not raise any new potential safety
risks |
| Auto close | No | Yes | The auto feature to close current exam whenever a new exam
is opened has been removed.
The difference has no impact on safety or efficacy of the
modified device and does not raise any new potential safety
risks |
| Chest CT View | No | Yes | The feature to compare images at the same time with
difference Window Width/Level has been removed in the
modified device.
The difference has no impact on safety or efficacy of the
modified device and does not raise any new potential safety
risks |
| 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 has
been removed.
The difference has no impact on safety or efficacy of the
modified device and does not raise any new potential safety
risks. |
| Hounsfield unit | No | Yes | The feature for using CT exam Hounsfield unit has been
removed.
The difference has no impact on safety or efficacy of the
modified device and does not raise any new potential safety
risks |
| Scout line | No | Yes | The scout line feature for CT and MR has been removed. The
difference has no impact on safety or efficacy of the modified
device 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 been
removed.
The difference has no impact on safety or efficacy of the
modified device and does not raise any new potential safety
risks |
| Sharpen preset | No | Yes | The sharpen preset database has feature been removed.
The difference has no impact on safety or efficacy of the
modified device and does not raise any new potential safety
risks |
| 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 device
and does not raise any new potential safety risks |
| Hanging protocol preset | No | Yes | The preset for layouts feature has been removed from
modified device.
The difference has no impact on safety or efficacy of the
modified device and does not raise any new potential safety
risks |
| Item | OmniVue 2 | OmniVue
Predicate | Description |
| Thumbnail view | Yes | Yes | Thumbnail image for exam |
| Chiropractic tools
Cobb's angle
Center mass
Atlas plane line
New Cobb's angle
Extended Cobb's angle
Horizontal deflection
Chiro ratio
Measure from horizontal
line | No | Yes | Specially designed tools for chiropractors has been removed
from modified device.
The difference has no impact on safety or efficacy of the
modified device and does not raise any new potential safety
risks |
| Arbitrary rotation | No | Yes | The rotate image with arbitrary angle feature has been
removed.
The difference has no impact on safety or efficacy of the
modified device and does not raise any new potential safety
risks |
| W/L for ROI only | No | Yes | The Window/Level feature in the ROI (region of interest) only
has been removed.
The difference has no impact on safety or efficacy of the
modified device and does not raise any new potential safety
risks |
| ROI | Yes | Yes | Region of Interest (ROI) |
| Measuring tools
Ruler
Angle | Yes | Yes | Measure angle or length |
| Customizing DICOM overlay | No | Yes | The feature to insert a customized DICOM overlay on the
image has been removed. The difference t has no impact on
safety or efficacy of the modified device and does not raise
any 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 the
modified device and does not raise any new potential safety
risks. |
| 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 the
modified device and does not raise any new potential safety
risks. |
| 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 the
function resides in a different module that indicates
L/R Mark on Image. This feature was a duplicate.
The difference has no impact on safety or efficacy of the
modified device and does not raise any new potential safety
risks. |
| Masking | No | Yes | The feature to mask image pixel if the pixel value is same with
certain color has been removed.
The difference has no impact on safety or efficacy of the
modified device and does not raise any new potential safety
risks. |
| Image stitching | No | Yes | The feature to stitch multiple images to one has been removed
The difference has no impact on safety or efficacy of the
modified device and does not raise any new potential safety
risks. |
| Annotation | Yes | Yes | Write text on the image |
| All series mode | Yes | Yes | Set multiple series as one series |
| Item | OmniVue 2 | OmniVue
Predicate | Description |
| DICOM information edit | Yes | Yes | Other module has it.
Only technician can modify DICOM information when they
made 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 been
removed.
The difference has no impact on safety or efficacy of the
modified device and does not raise any new potential safety
risks. |
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:
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
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 _______________________________________________________________________________________________________________________________________________________________
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