LEONARDO SYNGO CARDIOLOGY WORKSTATION

K042203 · Siemens Medical Solutions USA, Inc. · LLZ · Sep 24, 2004 · Radiology

Device Facts

• Record ID: K042203
• Device Name: LEONARDO SYNGO CARDIOLOGY WORKSTATION
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The LEONARDO syngo Cardiology Workstation is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media. The LEONARDO syngo Cardiology Workstation can be configured as a stand-alone diagnostic review and post-processing workstation 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.

Device Story

LEONARDO syngo Cardiology Workstation; universal imaging platform based on Windows XP; functions as medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images/data. Configurable with various syngo or Windows-based software options/clinical focus packages for post-processing diagnostic information. Used by physicians in clinical settings to aid evaluation of cardiological and radiological examinations; assists in diagnosis and treatment planning. Marketed as software-only solution or complete hardware/software workstation. Supports DICOM formatted images. Healthcare providers use output to inform clinical decision-making; benefits patient through enhanced diagnostic review and post-processing capabilities.

Clinical Evidence

No clinical data. Safety and effectiveness are supported by risk analysis, software development, verification, and validation testing adhering to industry standards.

Technological Characteristics

Software-only or hardware/software workstation; Windows XP operating system; supports DICOM formatted images; installed by Siemens service engineers; risk management via hazard analysis and verification/validation testing.

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 for patients undergoing cardiological and radiological examinations.

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 (K040970)

Submission Summary (Full Text)

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K04 2203

Siemens Medical Solutions, Inc 510(k) for LEONARDO syngo Cardiology

## 510(k) Summary

# SEP 2 4 2004

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.

## I. GENERAL INFORMATION

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

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

Device Name:

- LEONARDO syngo Cardiology Workstation Trade Name: .
- Picture Archiving and Communications System (PACS) Classification: ●
- Radiology Classification Panel: .
- 21 CFR 8892.2050 CFR Section: .
- Class II . Device Class:
- LLZ . Product Code:

Date of Preparation of Summary: August 5th, 2004

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

#### Device Description and Intended Use: .

This premarket notification covers Siemens LEONARDO syngo Cardiology Workstation syngo is a universal imaging platform based on Windows XP. LEONARDO syngo Cardiology offers a comprehensive cardiology solution to view, optimize, post-process diagnostic information and aid the doctors in the evaluation of digital cardiological and radiological examinations and patient information.

Due to special customer requirements based on the modality image type and the clinical focus, the LEONARDO syngo Cardiology Workstation can be configured with different combinations of clinical applications. syngo applications can be

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added to the LEONARDO syngo Cardiology Workstation either individually or as clinical focus packages.

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

The LEONARDO syngo Cardiology Workstation 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.

#### . Technological Characteristics:

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

#### General Safety and Effectiveness Concerns: .

The device labeling contains instructions for use and any necessary cautions and warning, 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 LEONARDO syngo Cardiology Workstation, addressed in this premarket notification, is substantially equivalent to the following commercially available device:

## LEONARDO (K040970)

The LEONARDO syngo Cardiology Workstation described in this premarket notification has the same intended use and similar technical characteristics as the device listed above.

In summary, Siemens is of the opinion that LEONARDO syngo Cardiology 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.

# SEP 2 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K042203 Trade/Device Name: LEONARDO syngo Cardiology Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ Dated: August 5, 2004 Received: August 16, 2004

Dear Ms. 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 (PMA), 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) I his letter will anow you to ought haling of substantial equivalence of your device to a legally premarket nothcation: "The PPF annums 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 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 Additionally, for questions on any -4639. Also, please note the regulation entitled, "Misbranding Other of Othphanos at ( notification" (21CFR Part 807.97) you may obtain. Other general of releveloc to premanted non-on-er the Act may be obtained from the Division of Small miormation on your respensional Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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## Intended Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________

## Indications for Use

The LEONARDO syngo Cardiology Workstation is a medical diagnostic workstation for The LEONARDO bylgo conmunication, and storage of medical images and data on exchange media.

The LEONARDO syngo Cardiology Workstation can be configured as a stand-alone diagnostic review and post-processing workstation with a variety of syngo or Windows agnoste forfow and possible intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques.

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

V Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR Prescription Use _ (Per 21 CFR 801.109)

David R. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __