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.

The Siemens ultrasound imaging systems are intended for the following applications. General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imagina".

Device Description

The modified software feature provides for the measurement of anatomical structures and for analysis packages that provide information.

AI/ML Overview

While the provided text describes the "Syngo US Workplace" and its intended use, it does not contain any information regarding specific acceptance criteria, device performance metrics, or any studies conducted to prove the device meets such criteria.

The document is a 510(k) summary from 2009 for the device, focusing on its regulatory classification, predicate devices, and intended use as a post-processing and measurement tool for ultrasound images. It highlights the Arterial Health Package (AHP) software feature for measuring Intima Media Thickness and referencing normative tables, but it does not include data from performance studies.

Therefore, I cannot populate the requested tables and information based on the given input.

Summary

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510(k) Summary Prepared April 27, 2009

K091286
Page 1 of 2

Sponsor:	Siemens Medical Solutions, Inc.,Ultrasound Division1230 Shorebird WayMountain View, California 94043
Contact Person:	Shelly Beere

MAY 15 2009

Contact Person: Shelly Pearce Telephone: (650) 694-5988 (650) 694-5580 Fax:
Submission Date: April 27, 2009
Device Name: syngo US Workplace
Common Name: System, Image Processing, Radiological

Classification:

Regulatory Class: ll Review Category: Tier II Classification Panel: Radiology

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

A. Legally Marketed Predicate Devices

syngo US Workplace, K060992, K072090; syngo AHP, K083149.

B. Device Description:

The modified software feature provides for the measurement of anatomical structures and for analysis packages that provide information.

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C. Intended Use

KC91286
Page 2 of 2

The Siemens ultrasound imaging systems are intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

MAY 15 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Siemens Medical Solutions USA, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 2500 Street, N.W. BUFFALO MN. 55313

K091286 Re:

Trade/Device Name: Syngo US Workplace Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Product Code: LLZ Dated: April 30, 2009 Received: May 1, 2009

Dear Mr. Job: . .

We have reviewed your Section -510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclobate) to tegains at date of the Medical Device Amendments, or to Connine.co pror to May 20, 2976, the encordance with the provisions of the Federal Food, Drug, devices that have occh recision of 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, morelors, mains of the Act include requirements for annual registration, listing of gonomics profices proficturing practice, labeling, and prohibitions against misbranding and adulteration.

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 or any I odotar buttor and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set do relator autocres (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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you don't be Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

(Gastroenterology/Renal/Urology) (240) 276-0115 21 CFR 876.xxx (240) 276-0115 (Obstetrics/Gynecology) . 21 CFR 884.xxx (240) 276-0120 21 CFR 892.xxx (Radiology) (240) 276-0100 Other

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

[signature]

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1.3 Indications for Use

K091286 510(k) Number (if known):

Device Name: Syngo US Workplace

Indications for Use:

The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

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)

Vorzu In Whang

Division of Reproductive, Abdominal an Radiologica 510(k) Number

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).