X-LEONARDO

K042995 · Siemens Medical Solutions USA, Inc. · LLZ · Nov 24, 2004 · Radiology

Device Facts

• Record ID: K042995
• Device Name: X-LEONARDO
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 24, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The X-LEONARDO is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media. The X-LEONARDO can be configured as a stand-alone diagnostic post-processing and reporting workstation. The X-LEONARDO can be configured with a variety of syngo- or Windows -based software options which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques and OEM options

Device Story

X-LEONARDO is a multimodality diagnostic workstation; operates on Windows XP platform using syngo software. Inputs include digital radiological images and patient data; supports DICOM format. Device functions as a platform for viewing, optimizing, post-processing, and storing medical images. Used in clinical settings by physicians to aid in diagnosis and treatment planning. Can be configured as a standalone workstation or with various clinical focus packages/OEM software options. Output is processed diagnostic information displayed for physician review; facilitates clinical decision-making by providing tools for image manipulation and reporting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Multimodality diagnostic workstation; Windows XP operating system; supports DICOM standard for image communication; software-only or hardware/software package configuration; syngo-based software platform.

Indications for Use

Indicated for use by physicians as a diagnostic workstation for viewing, manipulating, communicating, and storing medical images and data to assist in diagnosis or treatment planning.

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

• LEONARDO Workstation (K040970)

Submission Summary (Full Text)

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K042995

#### NOV 2 4 2004 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

#### GENERAL INFORMATION ﺘﮯ

Establishment:

| Address: | Siemens Medical Solutions, Inc.<br>51 Valley Stream Parkway<br>Malvern, PA 19355 |
|----------|----------------------------------------------------------------------------------|
|----------|----------------------------------------------------------------------------------|

- 2240869 . Registration Number:
- Contact Person: Mrs. Ana Ladino . Technical Specialist Regulatory Submissions Telephone: [phone] Telefax: [phone]

### Device Name:

| Trade Name: | X-LEONARDO |
|-----------------------|----------------------------------------------------|
| Classification: | Picture Archiving and Communications System (PACS) |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |

- Device Class: Class II
- . LLZ Product Code:

Date of Preparation of Summary: October 20, 2004

### II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION

#### . Device Description and Intended Use:

This Premarket Notification covers Siemens X-LEONARDO syngo-based multimodality workplace. syngo is a universal imaging platform based on Windows XP. The X-LEONARDO Workstation offers a comprehensive solution to view, optimize, and post-process diagnostic information and to aid the doctors in the evaluation of digital radiological examinations and patient information.

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Due to special customer requirements based on the modality image type and the clinical focus, the X-LEONARDO Workstation can be configured with different combinations of clinical applications. syngo applications can be added to the X-LEONARDO multi-modality workplace either individually or as clinical focus packages.

The X-LEONARDO is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

The X-LEONARDO can be configured with a variety of syngo- or Windows based software options, which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available OEM applications.

#### Technological Characteristics: .

The X-LEONARDO will be marketed as a software only solution for the end-user (with recommended hardware requirements) or as a complete workstation for the end-user (hardware and software package). It will be installed by Siemens service engineers. The X-LEONARDO Workstation described supports DICOM formatted images and information. The workstation is based on the Windows XP operating svstem.

#### General Safety and Effectiveness Concerns: .

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

#### Substantial Equivalence: .

The X-LEONARDO Workstation, addressed in this Premarket Notification, is substantially equivalent to the following commercially available device:

LEONARDO Workstation (K040970)

The X-LEONARDO Workstation described in this Premarket Notification has the same intended use and similar technical characteristics as the device listed above.

In summary, Siemens believes that the X-LEONARDO Workstation does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 2 4 2004

Ms. Ana Ladino Technical Specialist, ' Regulatory Submissions Siemens Medical Systems, Inc. 51 Valley Stream Parkway MALVERN PA 19355

Re: K042995

Trade/Device Name: X-LEONARDO Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems

Regulatory Class: II Product Code: 90 LLZ Dated: October 20, 2004 Received: November 1, 2004

Dear Mr. Ladino:

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.

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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 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 807.97). 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/cdrb/dsmaldsmamain.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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## Indications for Use

| 510(k) Number (if known): | K042995 |
|---------------------------|------------|
| Device Name: | X-LEONARDO |

### Indications for Use

The X-LEONARDO is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

The X-LEONARDO can be configured as a stand-alone diagnostic post-processing and reporting workstation.

The X-LEONARDO can be configured with a variety of syngo- or Windows -based software options which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques and OEM options

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OR

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________