UNDECIDED

K041484 · Siemens Medical Solutions USA, Inc. · LLZ · Jul 30, 2004 · Radiology

Device Facts

• Record ID: K041484
• Device Name: UNDECIDED
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jul 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

syngo TrueD is a medical diagnostic application for viewing, image manipulation, 3D visualization and comparison of medical images. syngo TrueD is intended for visualization and comparison of modalities and/or multiple time-points into a single dataset that accurately represents the information from the initial data. The input datasets could be functional 3D volumes (e.g. PET and SPECT) and/or anatomic 3D volumes (e.g. CT and MR). This "fusion" of data may be viewed in a number of output formats including MIP and volume rendering. syngo TrueD enables visualization of information that would otherwise have to be visually compared unformally. syngo TrueD provides analytical tools to help the user assess, and document any morphological or functional activity at diagnostic examinations and therapy follow-up. syngo TrueD is designed to support the evaluation, quantification, follow-up and documentation of any such lesions. Note: The clinician retains the ultimate responsibility for making the pertinent clinical decisions and practices and visual comparison of the separate unregistered images. syngo TrueD is a complement to these standard procedures.

Device Story

syngo TrueD is a software-only image manipulation tool for 3D volume datasets. It takes existing DICOM-formatted imaging data from multiple modalities (e.g., PET, SPECT, CT, MR) or different time-points as input. The device performs data fusion, aligning and assembling these datasets into a single representation. It provides visualization tools, including Maximum Intensity Projection (MIP) and volume rendering, and allows for simple quantitative measurements. Used in clinical settings by trained professionals, the software assists in the visual assessment, quantification, and documentation of morphological or functional activity, such as oncological lesions. By enabling the comparison of registered datasets, it supports clinicians in therapy follow-up and diagnostic decision-making. The clinician retains ultimate responsibility for clinical interpretation.

Clinical Evidence

No clinical data provided. The submission relies on bench testing, hazard analysis, and software design descriptions to demonstrate safety and effectiveness, consistent with the FDA's Reviewers Guidance for Computer Controlled Medical Devices.

Technological Characteristics

Software-only solution; requires specific hardware. Operates on Windows XP. Supports DICOM standard for image data. Features include 3D volume fusion, MIP, volume rendering, and quantitative measurement tools. No patient-contacting materials.

Indications for Use

Indicated for clinicians to visualize, compare, and quantify morphological or functional medical images from multiple modalities (e.g., PET, SPECT, CT, MR) or multiple time-points. Used for oncological evaluation, therapy follow-up, and lesion assessment. No specific age or gender restrictions; intended for use by trained professionals.

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)
• Lung CARE CT Software Package (K033374)
• Advantage Windows CT/PET Fusion (K010336)
• Leonardo Workstation (K040970)

Submission Summary (Full Text)

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K041484

#### 510(k) Summary JUL 3 0 2004

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

### General Information

### Manufacturer Facility (Developer) Siemens Medical Solutions USA, Inc. 51 Valley Stream Pkwy Malvem, PA 19355 Establishment Registration Number: 2240869

## Manufacturer Facility (Contract Manufacturer)

Siemens Medical Solutions USA, Inc. 2501 North Barrington Rd. Hoffman Estates, IL 60195-7372 Establishment Registration Number: 1423253

#### Contact Person

Richard Andersen Manager of Quality Assurance Phone: [phone] Fax: [phone]

### Device Name and Classification

| Trade Name: | syngo TrueD |
|----------------------|---------------------------------------------|
| Classification Name: | Picture Archiving and Communications System |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |

## Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

# Device Description and Intended Use

syngo TrueD is image manipulation software that is intended to assemble existing datasets from imaging modalities into a single dataset that accurately represents the information from the initial data. This "fusion" of data from multiple modalities will be performed on 3D volume datasets and may be represented in a number of output formats including MIP and volume rendering. Additionally, simple quantitative measurements may be made and subsequently compared to a dataset acquired at a different point in time.

More detailed information regarding the device can be found in the System Description included in Section 2 as well as in the technical information in Section 4.

### Technological Characteristics

syngo TrueD will be marketed as a software only solution for the end-user (with recommended hardware requirements) .It will be installed by Siemens service engineers.

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syngo TrueD supports DICOM formatted images and information. It is based on the Windows XP operating system.

### Safety Information

Sarety Information
A summary of the software design description, hazard analysis, and technical and safety information can be found in the attached submission. The results of the hazard analysis, moonlined with the appropriate preventive measures taken indicate the device is of minor Contonious with the appropriate August 29, 1991 issue of the "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review".

The device has no patient contacting materials and is utilized only by trained The device Thas no pations of the device is evaluated by trained professionals allowing sufficient review for identification and intervention in the event of a malfunction. Device sutten review for receinciente the appropriateness of a referral. The device does not impact the quality or status of the original acquired data.

#### Substantial Equivalence:

Substantial Equivalentially equivalent, both in intended use and technically, to the following devices:

| Predicate Device Name | FDA Clearance<br>Number |
|---------------------------------|-------------------------|
| syngo Multimodality Workstation | K010938 |
| Lung CARE CT Software Package | K033374 |
| Advantage Windows CT/PET Fusion | K010336 |
| Leonardo Workstation | K040970 (in review) |

In summary, Siemens is of the opinion that syngo TrueD 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/2 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text around the perimeter reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center appears to be three stylized, abstract shapes that could be interpreted as birds in flight or flowing lines.

JUL 3 0 2004

Food and Drug Administration 00 Corporate Boulevard deville MD 20050

Siemens Medical Solutions USA, Inc. c/o Mr. Glenn Luchen Staff Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. MELVILLE NY 11747-3081

Re: K041484

Trade/Device Name: syngo TrueD Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: July 14, 2004 Received: July 15, 2004

Dear Mr. Luchen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamined the device is substantially equivalent (for the indications ferenced above and naro uses.
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regally actuated the Medical Device Amendments, or 10 commerce provision to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have occh roomssing in avere 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, therefore, market the act include requirements for annual registration, listing of gencial controls provisions of the tice, 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 your device is elassified (500 above) ... Existing major regulations affecting your device can be it may be subject to adament. 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 I Tease oc accermination that your device complies with other requirements of the Act that I DA has made a doler minutions administered by other Federal agencies. You must of any I ederal statules and regulates.
comply with all the Act's requirements, including, but not limited to: registration and listing Comply with an the rioe Frequiremently (1) CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 007), laboming (21 CFR Part 820); and if applicable, the electronic forth in the quality byevelib (sections 531-542 of the Act); 21 CFR 1000-1050.

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

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo lotter 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.

Sincercly yours,

Nancy C. Brydon

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): | K041484 |
|---------------------------|-------------|
| Device Name: | syngo TrueD |

## Indications For Use:

syngo TrueD is a medical diagnostic application for viewing, image manipulation, 3Dsyngo Trucib is a modical of medical images. syngo TrueD is intended for visualization and companson of modalities and/or multiple time-points into a single datasce that accurately represents the information from the initial data. The a single datasets could be functional 3D volumes (e.g. PET and SPECT) and/or anatomic Input uatascis court be runctional bis "fusion" of data may be viewed in a number of output formats including MIP and volume rendering.

syngo TrueD enables visualization of information that would otherwise have to be syngo Truct Chaires Visuanzation of TrueD provides analytical tools to help the user visually compared unformedialy. 97%8 morphological or functional activity at diagnostic assess, and document any eningions. syngo TrueD is designed to support the and therapy fonow-up examination the user to confirm the absence or presence of oncological working evaluation, quantification, follow-up and documentation of any such lesions.

Note: The clinician retains the ultimate responsibility for making the pertinent Note. The enmends returns and practices and visual comparison of the separate unregistered images. syngo TrueD is a complement to these standard procedures.

(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:inline-block;"> <div style="display:inline-block;">✓</div> </div> | OR Over-The-Counter Use |
|------------------|---------------------------------------------------------------------------------------|-------------------------|
| | (Per 21 CFR 801.109) | |

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041484