EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM

K051809 · Medical Insight A/S · LLZ · Aug 15, 2005 · Radiology

Device Facts

• Record ID: K051809
• Device Name: EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM
• Applicant: Medical Insight A/S
• Product Code: LLZ · Radiology
• Decision Date: Aug 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The Medical Insight Easyl/iz™ PACS System is a Diagnostic Softcopy Reading software package to be used for primary diagnosis and clinical review of digital radiology images. The product utilizes the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows XP, Linux). The product interfaces to existing imaging equipment using the DICOM PS 3.1-2000 (Digital Imaging And Communications In Medicine) standard communication protocol as described and developed by ACR. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 M-pixel resolution and meets other technical specifications reviewed and accepted by the US FDA. The system does not permanently store or produce original medical images.

Device Story

EasyViz is a diagnostic softcopy reading workstation software; receives DICOM images from remote servers; displays images on standard PC hardware; enables primary diagnosis and clinical review by radiologists and referring physicians. Features include image measurement, annotation, cine tools, comparison modes, and layout options. Operates on standard TCP/IP networks; utilizes local cache for temporary storage. Does not permanently store or produce original images. Healthcare providers use the system to view and manipulate images to facilitate clinical decision-making and diagnosis.

Clinical Evidence

Bench testing only. Extensive software and hardware testing performed by internal staff and potential customers to validate diagnostic functionality and performance.

Technological Characteristics

Software-based PACS reading system; runs on Intel Pentium-based PCs with Windows XP or Linux. Uses DICOM PS 3.1-2000 communication protocol; TCP/IP networking. Features include proprietary image compression, graphical UI, and standard monitor support. No permanent image storage.

Indications for Use

Indicated for primary diagnosis and clinical review of digital radiology images in healthcare settings. Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images. Mammographic interpretation requires FDA-approved 5 M-pixel resolution monitors.

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

• Stentor iSite Radiology Workstation (K042292)
• Aquariusnet (K011142)
• Aquarius Workstation (K012086)

Submission Summary (Full Text)

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K051809

## Easyviz

# Medical Insight

AUG 1 5 2005

## 510(k) SUMMARY

In accordance with the provisions of the Safe Medical Device Act of 1990, In accordance with the providing of the Gale Modical 2011
Medical Insight, is providing a summary of safety and effectiveness information
Medical Insight, is providing a summ regarding the EasyViz software.

- Company Identification 1.1
Medical Insight A/S 200 South Wacker Drive Chicago, IL 60606 Contact: Andy B. Dobbs, Ph.D. Tel [phone] email: [e-mail]

- Official Correspondent 1.2
Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro CA USA 94578-1116 Tel: [phone] Fax: [phone] Email: [e-mail]

- Date of Submission 1.3
June 30, 2005

- Device Name 1.4
Classification Name: Common/Usual Name: Proprietary Name:

PACS Soft-copy reading system EasyViz(tm)

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| Hovedgaden 451<br>Hedehusene 2640 Denmark<br>Tel: [phone]<br>Fax: [phone] | Medical Insight A/S<br>www.medical-insight.com<br>[e-mail] | 200 South Wacker Drive<br>Chicago 60606 IL USA<br>Tel: [phone]<br>Fax: [phone] |
|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|

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

EasyViz

Image /page/1/Picture/1 description: The image shows the words "Medical Insight" in a stylized font. The words are in black and are slanted slightly to the right. To the right of the words is a black and white image of an eye.

Image /page/1/Picture/2 description: The image shows a stylized drawing of an eye. The eye is open, with a visible iris and pupil. The eyebrow is thick and arched above the eye. The drawing is simple and uses bold lines to define the shapes of the eye and eyebrow.

#### Substantial Equivalence 1.5

The EasyViz(tm) has the same intended uses and technical The EasyViz(In) Thas Tine Sune Interest (K042292) and characteristics as the Olentor Rate Rand Aquariusnet (K011142 and K012086 respectively).

### Device Description and Intended Use 1.6

The EasyViz(tm) system is designed as a diagnostic reading The EasyViz(th) system, which will be packaged with standard PC hardware workstation system, which will be package referring physicians.

EasyViz(tm) is capable of receiving and displaying DICOM images.

Images sent to EasyViz(tm) are converted into formats suitable for Images sent to Easyviz(in), and are temporarily stored in a local cache viewing in its framework, and are conspitiz(tm) to create JPEG and (themory). The algonalino a and accepted protocols.

Images sent to EasyViz(tm) can be viewed using an executable images sent to Easyniz(im) our be newspaper or other devices equipped with the appropriate hardware.

EasyViz(tm) uses standard "off-the-shelf" PC hardware and EasyViz(tim) uses standard TCP/IP stack. TCP/IP stack. The network communicates using the standard 100 stack is superfluous to EasyViz(tm).

#### Software Development 1.7

Medical Insight certifies that the EasyViz(tm) system is designed, Medical insight cellinos that according to written procedures. These procedures identify individuals within the organization

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| Hovedgaden 451<br>Hedehusene 2640 Denmark<br>Tel: [phone]<br>Fax: [phone] | Medical Insight A/S<br>www.medical-insight.com<br>[e-mail] | 200 South Wacker Drive<br>Chicago 60606 IL USA<br>Tel: [phone]<br>Fax: [phone] |
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Image /page/2/Picture/1 description: The image shows the words "Medical Insight" in a stylized font. To the right of the words is a graphic of an eye. The words and the eye graphic appear to be a logo. The text is in bold and slanted.

responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The coding and testing, validation tooling and to provide diagnostic software "developed" for this "produce" in the intended users.

#### Safety and Effectiveness 1.8

## General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and indications for use.

The optional hardware components specified are all "off the shelf" computer components.

## Validation and Effectiveness:

Extensive testing of the software and hardware have been performed Extensive testing of the Sonward and no halfty control staff, and by potential customers.

### Substantial Equivalence:

The EasyViz(tm) Client is a software package used to receive images The EasyViz(th) Ollent is a Soltharo passage
from the EasyViz(tm) Server. It provides the user Diagnostic quality images and the tools to make a diagnosis.

EasyViz(tm) is substantially equivalent to the Stentor iSite Radiology EasyViz(tim) is Substantially Oquivalers Workstation and Aquariusnet (K011142 and K012086 respectively).

It is our conclusion that there is no software component in the EasyViz(tm) product, or hardware component which would be used in EasyViz(tim) product, or nanaware of that we know of whose failure or latent design flaw would be expected to result in death or tallure of latent design han tround of Concern" of the EasyViz(tm)

Page Q-4 / Q-6

| Hovedgaden 451<br>Hedehusene 2640 Denmark | Medical Insight A/S | 200 South Wacker Drive<br>Chicago 60606 IL USA |
|-------------------------------------------|--------------------------|------------------------------------------------|
| Tel: [phone] | www.medical-insight.com | Tel: [phone] |
| Fax: [phone] | [e-mail] | Fax: [phone] |

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

EasyViz

Image /page/3/Picture/1 description: The image shows the words "Medical Insight" in a bold, sans-serif font. The words are slightly slanted to the right. To the right of the words is a stylized image of an eye.

product is "minor".

·

Page Q-5 / Q-6

| Hovedgaden 451 | Medical Insight A/S | 200 South Wacker Drive |
|-------------------------|--------------------------|------------------------|
| Hedehusene 2640 Denmark | www.medical-insight.com | Chicago 60606 IL US |
| Tel: [phone] | [e-mail] | Tel: [phone] |
| Fax: [phone] | | Fax: [phone] |

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

Image /page/4/Picture/0 description: The image shows the word "Easyviz" in a bold, sans-serif font. The text is black against a white background. The word appears to be a logo or brand name.

Image /page/4/Picture/1 description: The image shows the words "Medical Insight" in a bold, sans-serif font. To the right of the words is a stylized image of an eye. The text and the eye graphic appear to be part of a logo or heading.

### Substantial Equivalence Chart 1.9

| Product Name | Medical<br>Insight<br>EasyViz | TeraRecon<br>Aquariusnet | TeraRecon<br>Aquarius<br>Workstation | Stentor-iSite<br>Radiology |
|-----------------------------------------------------|-------------------------------|--------------------------|--------------------------------------|----------------------------|
| Print to Paper Capability | Yes | Yes | Yes | Yes |
| Graphical Ul | Yes | Yes | Yes | Yes |
| Windows O.S. - Client | Yes | Yes | Yes | Yes |
| Uses Standard. Monitor | Yes | Yes | Yes | Yes |
| Scales Image to Display. | Yes | Yes | Yes | Yes |
| Image Input | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
| Images stored on remote<br>NT server | Yes | Yes | Yes | Yes |
| Network Protocol | TCP-IP | TCP-IP | TCP-IP | TCP-IP |
| Compression | Proprietary | Proprietary | Proprietary | Wavelet |
| Annotation | Yes | Yes | Yes | Yes |
| Image Measurement | Yes | Yes | Yes | Yes |
| Cine tool | Yes | Yes | Yes | Yes |
| Comparison Mode | Yes | Yes | Yes | Yes |
| Review Report from RIS | Yes | Yes | Yes | Yes |
| Designed for Use Inside<br>and Outside of Radiology | Yes | Yes | Yes | Yes |
| Flip / Rotate of Images | Yes | Yes | Yes | Yes |
| User Log In | Yes | Yes | Yes | Yes |
| Multiple Layout Options | Yes | Yes | Yes | Yes |
| WW/WL control & Pre-sets | Yes | Yes | Yes | Yes |
| Patient & Study Browser | Yes | Yes | Yes | Yes |

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| Hovedgaden 451<br>Hedehusene 2640 Denmark<br>Tel: [phone]<br>Fax: [phone] | Medical Insight A/S<br>www.medical-insight.com<br>[e-mail] | 200 South Wacker Drive<br>Chicago 60606 IL USA<br>Tel: [phone]<br>Fax: [phone] |
|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Insight A/S % Mr. Gary J. Allsebrook Official Correspondent Regulatory Management Services 16303 Panoramic Way SAN LEANDRO CA 94578-1116

Re: K051809

Trade/Device Name: Medical Insight, EasyViz™ PACS System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: LLZ Dated: June 30, 2005 Received: July 5, 2005

Dear Mr. Allsebrook:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

AUG 1 5 2005

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This letter will allow you to begin marketing your device as described in your Section 510(k) I fills letter will anow you to begin mantenes ?
premarket notification. The FDA finding of substantial equivalence of your device to a legally prematication. The PDF maing or our device and thus, permits 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 Part 801), please If you desire specific advice for your do the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entires, to the responsibilities under the Act from the 807.97). I ou may obtain other general 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## K051809

Device Name: Medical Insight, EasyViz™ PACS System

Indications For Use:

The Medical Insight Easyl/iz™ PACS System is a Diagnostic Softcopy Reading software package to be used for primary diagnosis and clinical review of digital radiology images.

The product utilizes the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows XP, Linux).

The product interfaces to existing imaging equipment using the DICOM PS 3.1-2000 (Digital Imaging And Communications In Medicine) standard communication protocol as described and developed by ACR.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 M-pixel resolution and meets other technical specifications reviewed and accepted by the US FDA.

The system does not permanently store or produce original medical images.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 901.109) | <div style="text-align:left;">✓</div> | OR | Over-the-Counter Use _____ |
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| | <div style="text-align:center;">____________________________</div> <div style="text-align:center;">(Division Sign-Off)</div> |
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FDA Indication for Use Form
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number: K051809
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