SYNGO US WORKPLACE

K060992 · Siemens Medical Solutions · LLZ · Apr 28, 2006 · Radiology

Device Facts

• Record ID: K060992
• Device Name: SYNGO US WORKPLACE
• Applicant: Siemens Medical Solutions
• Product Code: LLZ · Radiology
• Decision Date: Apr 28, 2006
• 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® US Workplace is used to accept and view post processed ultrasound images, to store and print images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM compliant PACS system.

Device Story

syngo US Workplace is a software application for personal computers used to view, store, print, and measure post-processed ultrasound images. Images are acquired by ultrasound systems, formatted, and transferred to the PC via CD-ROM, DVD, or network connection. The device functions as a radiological image processing system, allowing clinicians to manipulate and analyze ultrasound data. It is intended for use in clinical environments where DICOM-compliant PACS systems are utilized. By facilitating the review and measurement of ultrasound images, the device supports healthcare providers in clinical decision-making and diagnostic workflows.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Software-based image processing system for personal computers. Operates on standard PC hardware. Supports DICOM-compliant image transfer via network, CD-ROM, or DVD. Functionality includes image viewing, storage, printing, and measurement tools.

Indications for Use

Indicated for viewing, storing, printing, and performing measurements on post-processed ultrasound images via a personal computer or DICOM-compliant PACS system. No specific patient population, age, or gender restrictions are defined.

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

• Siemens Ultrasound Systems (K052410)
• Siemens Ultrasound Systems (K051139)
• Siemens Ultrasound Systems (K041319)
• Siemens Ultrasound Systems (K032144)
• Siemens Ultrasound Systems (K022567)
• Siemens Ultrasound Systems (K050034)
• Siemens Ultrasound Systems (K033196)
• Siemens Ultrasound Systems (K023720)
• Siemens Ultrasound Systems (K021497)
• Siemens Ultrasound Systems (K010950)
• Siemens Ultrasound Systems (K891449)
• Siemens Ultrasound Systems (K904017)
• Siemens Ultrasound Systems (K052895)
• Siemens Ultrasound Systems (K022896)
• TomTec Image Arena (K040546)

Submission Summary (Full Text)

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K060992

## 510(K) SUMMARY syngo US Workplace Prepared April 24, 2006

APR 2 8 2006

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.

#### 1. Submitted By:

Siemens Medical Solutions USA, Inc., Ultrasound Division 1230 Shorebird Way Mountain View, CA 94043

## Contact Person:

Sheila W. Pickering Regulatory Affairs

Phone: [phone] FAX: [phone]

## Date Prepared:

March 30, 2006

Proprietary Name: 2. syngo® US Workplace

## Common/ Usual Name:

System, Image Processing, Radiological

## Classification Name:

21 CFR 892.2050 Picture Archiving and Communications System 21 CFR # 892.2050 Product Code 90-LLZ

#### 3. Predicate Devices:

Siemens Ultrasound Systems (K052410, K051139, K041319, K032144. K022567,K050034,K033196,K023720,K021497,K010950,K891449,K904017, K052895, K 022896) and the TomTec Image Arena (K040546)

#### 4. Device Description:

The syngo US Workplace is used to view images, to store and print images, and to make measurements on images using a personal computer. The software is userinstallable. The images are acquired by ultrasound systems using standardized formatting and are transferred from the ultrasound system to the PC hosting the software by CD-ROM and DVD or a network connection.

#### 5. Intended Uses:

syngo US Workplace is used to accept and view post processed ultrasound images, to store and print images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM compliant PACS system.

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### Technological Comparison to Predicate Device: 6.

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APR 2 8 2006

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Siemens Medical Solutions USA, Inc., Ultrasound Group % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K060992

Trade/Device Name: syngo® US Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 7, 2006 Received: April 11, 2006

Dear Mr. Job:

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.

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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.

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/cdrh/industry/support/index.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 : K060992

Device Name: syngo® US Workplace

Indications For Use:

syngo® US Workplace is used to view post processed ultrasound images, to store and print images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM compliant PACS system.

**Prescription Use**
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Manuel Buadon

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(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 5 I ()(k) Number _