LEONARDO

K040970 · Siemens Medical Systems, Inc. · LLZ · Jul 8, 2004 · Radiology

Device Facts

• Record ID: K040970
• Device Name: LEONARDO
• Applicant: Siemens Medical Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jul 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The LEONARDO is a medical diagnostic workstation for viewing, manipulation, medical images and data on exchange media. The LEONARDO can be configured as a satellite console, sharing a database with the main console of a CT, MR, or radiographic/fluoroscopic imaging system, as well as stand-alone diagnostic review and post-processing workstation. The LEONARDO can be configured with a variety of syngo- or Windows XP-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 is a multimodality diagnostic workstation; operates on Windows XP platform using syngo software. Inputs include digital radiological images (CT, MR, radiographic/fluoroscopic) and data from exchange media or networked imaging systems. Functions as satellite console or standalone workstation; enables viewing, manipulation, and post-processing of diagnostic images. Used by physicians in clinical settings to assist in diagnosis and treatment planning. Output consists of processed diagnostic images and clinical data displayed for physician review. Benefits include centralized access to multimodality imaging data and advanced post-processing capabilities to support clinical decision-making.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by risk management, software development processes, and validation testing.

Technological Characteristics

Workstation hardware or software-only solution; Windows XP operating system; supports DICOM standard for image/data exchange. Configurable with various syngo-based post-processing software packages. Operates as a networked satellite console or standalone unit.

Indications for Use

Indicated for use by physicians as a medical diagnostic workstation for viewing, manipulating, and post-processing digital radiological images and patient data from CT, MR, or radiographic/fluoroscopic imaging systems 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

• syngo Multimodality Workstation (K010938)

Submission Summary (Full Text)

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Ko40970

Siemens Medical Solutions, Inc 510(k) for LEONARDO

### 510(k) Summary

# JUL - 8 2004

This summary of 510(k) safety and effectiveness information is being submitted in I mis Sunniary of Drogity career of SMDA 1990 and 21 CFR §807.92.

## I. GENERAL INFORMATION

Establishment:

- Siemens AG Address: t Medical Solutions Henkestrasse 127 D-91052 Erlangen Germany
- Registration Number: 2240869 .

Ana Ladino Contact Person: Technical Specialist Regulatory Submissions Telephone: [phone] [phone] Telefax:

Device Name:

.

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

Date of Preparation of Summary:_ April 9th, 2004

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

### Device Description and Intended Use: .

This premarket notification covers Siemens LEONARDO syngo-based multimodality workplace. syngo is a universal imaging platform based on Windows XP. Leonardo offers a comprehensive solution to view, optimize, post-process diagnostic information and 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 Due to special bastomer roupo can be configured with different combinations of clinical locus, the LEONARD can be added to the LEONARDO multientired uppreaders individually or as clinical focus packages.

The LEONARDO is a medical diagnostic workstation for viewing, manipulation, The EDONATED O 25 medical images and data on exchange media.

The LEONARDO can be configured as a satellite console, sharing a database with the main console of a CT, MR, or radiographic/fluoroscopic imaging system, as well as stand-alone diagnostic review and post-processing workstation.

The LEONARDO can be configured with a variety of syngo- or Windows XP-I he LEON free options, which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques.

#### Technological Characteristics: .

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

### General Safety and Effectiveness Concerns: .

General Safety and Enecir. 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, nazards. These potenation testing. To minimize electrical, mechanical, and veliation hazards, Siemens adheres to recognized and established industry practice and standards.

#### Substantial Equivalence: .

The LEONARDO syngo Multimodality Workstation, addressed in this premarket notification, is substantially equivalent to the following commercially available device:

syngo Multimodality Workstation (K010938)

The LEONARDO Workplace 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 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 Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The eagle is composed of three curved lines, and the text is in all caps.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 2004

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

Re: K040970

Trade/Device Name: LEONARDO Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ Dated: April 9, 2004 Received: April 14, 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 I ou may, ates 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) 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. Ixxx | [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 yours,

Nancy C. Bugdon

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): | k040970 |
|---------------------------|----------|
| Device Name: | LEONARDO |

## Indications for Use

The LEONARDO is a medical diagnostic workstation for viewing, manipulation, The LEONARDO Is a - medical images and data on exchange media.

The LEONARDO can be configured as a satellite console, sharing a database with the The LEONARDO can oc comigated as a satins comes, as someon
main console of a CT, MR, or radiographic/fluoroscopic imaging system, as well as standmain consore of a view and post-processing workstation.

The LEONARDO can be configured with a variety of syngo- or Windows XP-based The LEONARDO can be contiguted to assist the physician in diagnosis or treatment soltware options, which are mixing available post-processing techniques.

(Please do not write below this line - continue on another page if needed)

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

V Prescription Use __

Over-The-Counter Use_ OR (Per 21 CFR 801.109)

Nancy C. Broydon

(Division Sign-Off))
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040970