ORG@NIZER, MODEL VERSION 3.0

K030363 · Ebit Sanita, S.P.A. · LLZ · Mar 27, 2003 · Radiology

Device Facts

• Record ID: K030363
• Device Name: ORG@NIZER, MODEL VERSION 3.0
• Applicant: Ebit Sanita, S.P.A.
• Product Code: LLZ · Radiology
• Decision Date: Mar 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Ebit Sanità Org@nizer software is a medical image management software device intended to be used for digital acquiring, viewing, processing, archiving, reporting and communicating ultrasound medical studies by qualified medical professionals, after proper installation on an appropriate hardware platform. This medical device is intended for the sole use of digital acquiring, viewing, processing, archiving reporting and communicating digital ultrasound studies. It does not have any influence in the way the medical image is produced, nor it is intended to control ionizing emissions or monitor vital physiological processes. The medical device is able to manage stand-alone or distributed medical image archives. It specifically provides the following added-value: ®Connecting diagnostic modalities for the purpose of centralising the image archiving for later image viewing, processing and reporting; @Establishing distributed points of access on conventional PCs for distributed image and report viewing and access.

Device Story

Org@nizer software functions as medical image management system for ultrasound studies; acquires, views, processes, archives, reports, and communicates digital images. Operates on standard PC hardware; connects diagnostic modalities to centralize archives; provides distributed access points for clinicians. Input consists of digital ultrasound studies; output includes displayed images, reports, and archived data. Clinicians use software to review still frames and cine-loops; perform measurements (distance, area, perimeter, velocity); apply annotations (text, lines); and adjust window-level, zoom, or panning. Device does not influence image acquisition or control ionizing radiation; intended for use by qualified medical professionals in clinical settings to facilitate diagnostic workflow and image access.

Clinical Evidence

No clinical data; bench testing only. Device functionality verified through comparison of technical specifications and intended use with predicate device.

Technological Characteristics

Software-based image management system; runs on Windows-based PC hardware. Supports DICOM connectivity. Features include image database management, still frame/cine-loop review, annotation (text, lines), and measurements (distance, area, perimeter, velocity). Archiving supported on hard disk, CD-R, and DVD-R. No image compression utilized.

Indications for Use

Indicated for qualified medical professionals to manage, view, process, archive, report, and communicate digital ultrasound studies.

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

• Applicare Radworks Medical Imaging Software W/ Quality Control Module (K982862)

Submission Summary (Full Text)

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K030363

510(k) Ebit Sanità Org@nizer Software Ebit Sanità, S.p.A.

MAR 2 7 2003

# 510(k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).

807.92(a)(1)

## Submitter Information

Colleen Hittle Densmore, Official Correspondent
The Anson Group, an Aventor company
7992 Castleway Drive
Indianapolis, IN 46250

| Phone: | [phone] |
|------------|----------------|
| Facsimile: | [phone] |

Contact Person: Colleen Hittle Densmore

| Date: | January 15, 2003 |
|-------|------------------|
|-------|------------------|

807.92(a)(2)

| Trade Name: | Ebit Sanità Org@nizer Software |
|--------------|--------------------------------|
| Common Name: | System, Image Processing |

| Classification: | |
|-------------------|----|
| Regulatory Class: | II |

| | FR Number | Product Code |
|-------------------------|-----------|--------------|
| Image Processing System | 892.2050 | 90-LLZ |

807.92(a)(3)
Predicate Device(s)

| Applicare | Radworks Medical Imaging Software |
|-----------|-----------------------------------|
| | W/ Quality Control Module |
| | K982862 |

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

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510(k) Ebit Sanità Org@nizer Software Ebit Sanità, S.p.A.

807.92(a)(4)

## Device Description

The Ebit Sanità Org@nizer software is a medical Image Management software device used for digital acquisition, viewing, processing, archiving, reporting and communicating ultrasound studies.

807.92(a)(5)

## Intended Use(s)

The Ebit Sanita Org@nizer software is intended to be used for digital acquiring, viewing, processing, archiving, reporting and communicating ultrasound medical studies by qualified medical professionals, after proper installation on an appropriate hardware platform.

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| Product | Ebit Sanità Org@nizer<br>Software<br>(This submission) | Applicare Medical Imaging<br>Radworks Medical Imaging<br>Software with Quality Control<br>Module<br>K982862 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 892.2050 LLZ<br>Class II | 892.2050 LLZ<br>Class II |
| Intended use | The Ebit Sanità Org@nizer software<br>is a medical image management<br>software device intended to be used<br>for digital acquiring, viewing,<br>processing, archiving, reporting and<br>communicating ultrasound medical<br>studies by qualified medical<br>professionals, after proper<br>installation on an appropriate<br>hardware platform | The RadWorks Quality Control Module is<br>intended to be used by authorized staff to<br>perform various quality control operations on<br>RadWorks imaging studies before they are made<br>available to other locations on the network.<br>These operations include confirming or editing<br>patient characteristics, reviewing the status<br>history of the study, adding or removing images,<br>combining with another study, renumbering<br>images, editing patient orientation information,<br>and setting or editing routing information. |
| Graphic User Interface | Yes | Yes |
| Platform | PC | PC |
| Operating System | Microsoft Windows<br>based | Microsoft Windows<br>based |
| Display Resolution | 1280x1024 | 2048x2560 |
| Image Resolution | From 8 bits grayscale and 24 bits<br>color | From 8 bits, 256 levels to 24 bits color |
| Image Communication | DICOM Compliant | DICOM Compliant |
| Image Compression | No image compression techniques<br>are utilized | Jpeg Loss-less;<br>Jpeg lossy |
| Image Archiving (Hard<br>Disk) | Yes | Yes |
| Image Archiving<br>(Removable Media) | CD-R; DVD-R, other Dicom Entities | CD-R; MOD; DVD-R, other Dicom Entities |
| Image Review | Still frame, Cine-loops, Window-<br>level, Zoom, Panning, Configurable<br>layout | Still frame, Cine-loops, Window-Level, Zoom,<br>Panning, Configurable layout |
| Image Processing | Annotation:<br>text, lines | Annotation:<br>arrows, text, lines, Circles |
| | Measurements: Distance, area,<br>perimeter, velocity | Measurements: distances, angles, pixel values,<br>pixel distribution, grey level statistics |
| Image Database | Yes | Yes |
| Image Management | Uncompressed / JPEG Lossy /<br>JPEG Loss-less | Uncompressed / JPEG Lossy /<br>JPEG Loss-less |

## Comparison Chart for Substantial Equivalence

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2003

Ebit Sanita, S.p.A. % Ms. Colleen Densmore The Anson Group 7229 Castleway Drive INDIANAPOLIS IN 46250

#### Re: K030363

Trade/Device Name: Org(@nizer Version 3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: January 31, 2003 Received: February 4, 2003

Dear Ms. Densmore:

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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely vours.

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

Page 2

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## Indications for Use Statement

| Applicant: | Ebit Sanità S.p.A. |
|---------------------------|--------------------|
| 510(k) Number (if known): | K030363 |

Ebit Sanità Org@nizer Software Device Name:

Indication For Use:

The Ebit Sanità Org@nizer software is a medical image management software device intended to be used for digital acquiring, viewing, processing, archiving, reporting and communicating ultrasound medical studies by qualified medical professionals, after proper installation on an appropriate hardware platform.

This medical device is intended for the sole use of digital acquiring, viewing, processing, archiving reporting and communicating digital ultrasound studies. It does not have any influence in the way the medical image is produced, nor it is intended to control ionizing emissions or monitor vital physiological processes. The medical device is able to manage stand-alone or distributed medical image archives. It specifically provides the following added-value:

®Connecting diagnostic modalities for the purpose of centralising the image archiving for later image viewing, processing and reporting;

@Establishing distributed points of access on conventional PCs for distributed image and report viewing and access.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use \/ OR Over The Counter ***_***

(PER 21 CFR, 801 109)

(optional Format 1-2-96)

David A. Symm

---

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030363

510(K) FILE - ORG@NIZER SOFTWARE