OMNIVISION

K110040 · Modern Module, Inc. · LLZ · Jan 26, 2011 · Radiology

Device Facts

• Record ID: K110040
• Device Name: OMNIVISION
• Applicant: Modern Module, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jan 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Indications for Use

OmniVision is intended to be used for the acquisition, storage, communication and viewing of medical Images.OmniVision receives images from imaging modalities via DICOM or imported It archives and displays these images for the use of medical specialists who are qualified directly. to operate radiological equipment and to record and diagnose medical images. It provides the user with a range of tools to assist them in viewing the images, such as zoom, filters and measurements, and with facilities to exchange images with other specialists. OmniVision is not intended for the acquisition of mammographic image data.

Device Story

OmniVision is a Picture Archiving and Communications System (PACS) for acquisition, storage, communication, and viewing of medical images; receives inputs from imaging modalities via DICOM or direct import; modular architecture includes viewer, database management, and printing modules; used by radiologists and orthopaedists in clinical settings; provides tools for window leveling, zoom, filters, and measurements; facilitates image exchange between specialists; does not control life-sustaining devices; requires qualified medical personnel for interpretation; benefits patient through efficient image management and diagnostic support.

Clinical Evidence

Bench testing only. Device performance verified against specifications and DICOM conformance standards. No clinical data provided.

Technological Characteristics

Autonomous software PACS; no hardware. Runs on standard PC hardware (e.g., HP, Dell, IBM) with MS Windows XP. Modular architecture; DICOM compliant. Features include image acquisition, storage, communication, and viewing tools (zoom, filters, measurements).

Indications for Use

Indicated for medical specialists qualified to operate radiological equipment to record and diagnose medical images. Not intended for acquisition of mammographic image data.

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

• dicomPACS (K070618)

Submission Summary (Full Text)

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510(k) Premarket Notification Modern Module Inc. - OminiVision March 30th, 2010

JAN 2 6 2011

Image /page/0/Picture/2 description: The image shows the text "KI10040" at the top, followed by a logo that says "Modern Module". The logo has a stylized "M" with the rest of the text in a simple font. The text is black and the background is white.

# 510 (K) Summary

Summary of functions of the device and its major components provided as part of the Premarket Notification for OmniVision

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| Date : | 30 March 2010 |
|-----------------|------------------------------------------------------------------------------------------------|
| Company Name : | Modern Module Inc. |
| Address: | C Bldg., Suite # 809 Woolim Lions Valley,<br>425 CheongChun-dong, Bupyung-ku<br>Incheon, Korea |
| Contact Person: | Samuel Koh / CEO |
| E-Mail : | [e-mail] |
| Tel.: | [phone] |
| Fax.: | [phone] |

| Device Trade Name: | OmniVision |
|-------------------------|----------------------------------------------------|
| Device Common Name : | Picture Archiving and Communications System (PACS) |
| Product Code : | LLZ |
| Regulation Number | 892.2050 |
| Device Classification : | Class II |
| Predicate Devices | dicomPACS |

| Predicate Devices | | Items | Predicate Device : | Subject Device | Remark |
|-----------------------|----------------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Trade Name | dicomPACS | 510(k) No. | K070618 | | |
| Common Name | Picture Archiving and Communications System (PACS) | Trade Name | dicomPACS | OmniVision | |
| Regulation Number | 892.2050 | | dicomPACS® is a software<br>system for the administration,<br>archiving, improvement and<br>compression of medical image<br>data for diagnosis. The images<br>are either acquired from imaging<br>modalities via DICOM or imported<br>directly. All images are archived<br>in a database as DICOM<br>compliant files. The data is<br>displayed on a computer monitor | OmniVision is intended to be<br>used for the acquisition, storage,<br>communication and viewing of<br>medical Images.<br>OmniVision receives images from<br>imaging modalities via DICOM or<br>imported directly. It archives<br>and displays these images for the<br>use of medical specialists who<br>are qualified to operate | |
| Device Classification | Class II | Indications for use | for diagnosis.<br>dicomPACS® also provides<br>services for administering the<br>data.<br>Lossy compressed<br>mammographic images and<br>digitized film screen images must<br>not be reviewed for primary image<br>interpretations. Mammographic<br>images may only be using an FDA<br>approved monitor that offers at<br>least 5 MP resolution and meets<br>other technical specifications<br>reviewed and accepted by FDA.<br>Functions to be carried out using<br>dicomPACS® are, for example,<br>but not limited to, adjustment of<br>window leveling, rotation, zoom, | radiological equipment and to<br>record and diagnose medical<br>images.<br>It provides the user with a range<br>of tools to assist them in viewing<br>the images, such as zoom, filters<br>and measurements, and with<br>facilities to exchange images with<br>other specialists.<br>OmniVision is not intended for the<br>acquisition of mammographic<br>image data. | |
| Product code | LLZ | | | | |
| Manufacturer | Oehm und Rehbein GmbH | | | | |
| 510(k) number | K070618 | | | | |

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Image /page/1/Picture/1 description: The image shows the words "Modern Module" in a stylized font. The word "Modern" is on the top line, and the word "Module" is on the bottom line. The first letter of "Modern" is stylized with two thick vertical lines.

Image /page/1/Picture/2 description: The image shows a grainy black and white picture. There are some numbers in the image, including 1, 315, and 23. The image is blurry and difficult to make out any specific details.

# Comparison between the Predicate Device and the OmniVlsion

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### 510(k) Premarket Notification Modern Module Inc. - OminiVision

| | and measurements.<br>dicomPACS® is meant to be<br>used by qualified medical<br>personnel only. All users must be<br>qualified to create and diagnose<br>radiological image data. | | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------|
| Product Availability | Available now | Available now | Similarity |
| | System | | |
| Architecture | Server & Client, Web-based<br>versions,<br>local servers & remote<br>archiving | Server & Client, Web-based<br>versions,<br>local servers & remote<br>archiving | Similarity |
| Operating System | Window XP | Window XP | Similarity |
| Hardware | HP, Dell, IBM | HP, Dell, IBM | Similarity |
| | Administration | | |
| System failure Alert | Available | Available | Similarity |
| | DICOM Compatibility | | |
| DICOM Worklist | Yes | Yes | similarity |
| DICOM Storage | Yes | Yes | similarity |
| DICOM Printer | Yes | Yes | Similarity |
| | Image Acquisition | | |
| Image Acquisition | DICOM radiology systems<br>Digital film scanner<br>Other imaging modalities | DICOM radiology systems<br>Digital film scanner<br>Other imaging modalities | Similarity |
| | Image Manipulation | | |
| Rotation * | Yes | Yes | similarity |
| Invert | Yes | Yes | similarity |
| Zoom In/Out | Yes | Yes | similarity |
| W/L Adjustment | Yes | Yes | similarity |
| Pan Image | Yes | Yes | similarity |
| Flipping | Yes | Yes | similarity |
| Image Crop | No | Yes | |
| | Image Post-Processing | | |
| Secondary<br>Processing | Organ specific type | Organ Specific Type | similarity |
| | Measurement | | |
| Length Measurement | Yes | Yes | similarity |
| Angle Measurement | Yes | Yes | similarity |
| Multiple Length<br>Measurement | Yes | Yes | similarity |
| | Backup | | |
| Storage Backup<br>method | CD/DVD, Flash Drive | CD/DVD, Flash Drive, URL | |
| Export Format | DICOM, TIFF, BMP, JPEG,<br>PNG | DICOM, BMP | |
| | Services | | |
| Support | 24/7 customer support for<br>application software. | 24/7 customer support for<br>application software, | similarity |
| Training | On/off site available | On/off site available | similarity |

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#### 510(k) Premarket Notification Modern Module Inc. - OminiVision

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Image /page/4/Picture/1 description: The image shows the words "Modern Module" stacked on top of each other. The word "Modern" is on the top and the word "Module" is on the bottom. The font is a simple sans-serif font and the text is black.

#### Description:

OmniVision is a Picture Archiving and Communications System (PACS), as is the predicate Device dicomPACS. All of them have been developed to acquire, store, communicate, display and process medical images. They offer features (e.g. window leveling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and orthopaedists, and required of all PACS solutions.

OmniVision has a modular system architecture, It consists of the basic application viewer for image viewing and processing, image storage and communication, and a number of other modules for database management, image acquisition, printing etc.

OmniVision conforms to the DICOM (Digital Image and Communications in Medicine) standard.

#### Indications for Use:

OmniVision is intended to be used for the acquisition, storage, communication and viewing of medical images.

OmniVision receives images from modalities via DICOM or imported directly. It archives and displays these images for the use of medical specialists who are qualified to operate radiological equipment and to record and diagnose medical images. It provides the user with a range of tools assist them in viewing the images. such as zoom, filters and measurements, and with facilities to exchange images with other specialists.

OmniVision is not intended for the acquisition of mammographic image data.

#### Technological Characteristics:

OmniVision is intended to be used for the acquisition, storage, communication and viewing of medical images. OmniVision is an autonomous software and involves no hardware. This largely applies to the predicate device dicomPACS.

OmniVision receives images from modalities via DICOM or imported directly. It archives and displays these images for the use of medical specialists who are qualified to operate radiological equipment and to record

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## 510(k) Premarket Notification

Modern Module Inc. - OminiVision

Image /page/5/Picture/2 description: The image shows the words "Modern Module" stacked on top of each other. The word "Modern" is on the top line, and the word "Module" is on the bottom line. The first letter of the word "Modern" is stylized with a black rectangle and a white letter M. The rest of the letters are in a simple, sans-serif font.

and diagnose medical images. It provides the user with a range of tools assist them in such as zoom, filters and measurements; and with facilities to exchange images with other specialists.

OmniVision does not control any life-sustaining devices. Specialists with adequate expert knowledge for competent human intervention interpret displayed or printed images and information.

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Omni\/ision runs on any hardware platform meeting the minimum system requirements.

OmniVision can be used with the server operating systems MS Windows XP

#### Testing:

Omnivision has been tested according to the specifications documented in this notification. It conforms to the DICOM standard as laid out in the included DICOM Conformance Statement. (Tab. 9 section 2)

#### Conclusion:

Omnivision is a medical device. OmniVision provides functionality comparable to that of its Predicate Device, dicomPACS and is intended for the same user and patient groups as its Predicate Device. Based on the indications for use, Technological Characteristics, performance testing and comparison to predicate device, the proposed OmniVision is substantially equivalent and has been shown to be safe and effective for its intended use

Image /page/5/Picture/12 description: The image is a black and white graphic that appears to be a map or some type of spatial representation. The image is mostly white, with black dots and lines scattered across the surface. The black markings are concentrated in the lower left quadrant of the image, with fewer markings in the upper right quadrant. The overall impression is that of a sparse and abstract representation of a geographical area or network.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure. The logo is black and white.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Modern Module Inc c/o Marc M. Mouser Engineering Leader Underwriters Laboratories. Inc. 2600 NW Lake RD. CAMAS, WA 98607

JAN 26 2011

Re: K110040

Trade/Device Name: OmniVision Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 10, 2010 Received: January 6, 2010

Dear Mr. Mouser:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803): and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary S. Postel

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K110040

Device Name: OmniVision

Indications for Use:

OmniVision is intended to be used for the acquisition, storage, communication and viewing of medical Images.OmniVision receives images from imaging modalities via DICOM or imported It archives and displays these images for the use of medical specialists who are qualified directly. to operate radiological equipment and to record and diagnose medical images.

It provides the user with a range of tools to assist them in viewing the images, such as zoom, filters and measurements, and with facilities to exchange images with other specialists.

OmniVision is not intended for the acquisition of mammographic image data.

AND/OR

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14 1.15.

Prescription Use X
(Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Barl D. Kunn

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number

Page 1 of _1_

000018