FOURSIGHT VIEWTOOL IMAGE VIEWER

K052895 · Siemens Medical Solutions USA, Inc. · LLZ · Oct 27, 2005 · Radiology

Device Facts

• Record ID: K052895
• Device Name: FOURSIGHT VIEWTOOL IMAGE VIEWER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Oct 27, 2005
• 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

Acceptance, transfer, display, storage, and digital processing of diagnostic ultrasound images. Image manipulation and quantification.

Device Story

fourSight ViewTool is a software application for personal computers used to view, store, print, and perform measurements on diagnostic ultrasound images. Images are acquired by ultrasound systems, saved in standardized formats, and transferred to the PC via CD-ROM. The software is user-installable. It enables clinicians to manipulate and quantify ultrasound data for diagnostic review. The device functions as a PACS-like image viewer, facilitating clinical decision-making by providing tools for image analysis and documentation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Software-based image viewer for PC. Operates on standardized ultrasound image formats. Functions include image display, storage, printing, and quantification. User-installable software.

Indications for Use

Indicated for the acceptance, transfer, display, storage, and digital processing of diagnostic ultrasound images, including image manipulation and quantification. Intended for prescription use.

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

• ACUSON Antares ultrasound systems (K050034)
• CSV12 Viewer Software (K022896)

Submission Summary (Full Text)

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K052895

# 510(K) SUMMARY

# fourSight ViewTool image viewer

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) Summarv.

#### 1. Submitted By:

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

# Contact Person:

Patrick J Lynch Regulatory Affairs

Phone: [phone] FAX: [phone]

# Date Prepared:

September 21, 2005

### 2. Proprietary Name:

fourSight ViewTool

# Common/ Usual Name:

System, Image Processing, Radiological

# Classification Name:

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

#### 3. Predicate Device:

- K050034, 01/13/2005, ACUSON Antares ultrasound systems
- 베 K022896, 10/02/2002, CSV12 Viewer Software

#### 4. Device Description:

The ViewTool is used to view volumes and images, to store and print images, and to make measurements on images using a personal computer. The software is user-installable. The images are acquired by ultrasound systems using standardized formatting and are transferred from the ultrasound system to the PC hosting the ViewTool software by CD-ROM.

#### 5. Intended Uses:

Acceptance, transfer, display, storage, and digital processing of diagnostic ultrasound images. Image manipulation and quantification.

#### 6. Technological Comparison to Predicate Device:

The FourSight ViewTool is substantially equivalent to the ACUSON Antares, cleared via K050034, the CSV12 Software Viewer, cleared via K022896. The ViewTool is used to view volumes and images, to store and print images, and to make measurements on images using a personal computer. The software is user-installable. The images are acquired by ultrasound systems using standardized formatting and are transferred from the ultrasound system to the PC hosting the ViewTool software by CD-ROM.

# End of 510(k) Summary

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 2005

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

Re: K052895 Trade/Device Name: fourSight™ ViewTool image viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 11, 2005 Received: October 14, 2005

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w c have reviewed your over essubstantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the encresure) to regally maniental Device Amendments, or to devices that have been May 20, 1770, the enatinents of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmed in aceonal of a premarket approval application (PMA). You may, therefore, market the do not require approval or a provisions of the Act. The general controls provisions of the Act device, sabject to the generalian, 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 Apployal); It they of cally of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA aceries announcements concerning your device in the Federal Register.

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that I Tease be devised drarmination that your device complies with other requirements of the Act or any I Drival statutes and regulations administered by other Federal agencies. You must comply with all the r caerar states and regulating, 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) This letter will anow you to begin manceing your intial equivalence of your device to a legally premarket nothication. The PDA miding of backminent of 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 If you desire specific advice for your device in a 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 Also, please note the regulation entition, "hisoriation on your responsibilities under the Act from the 807.97). You may obtain other general international and Consumer Assistance at its toll-free number (800) Division of Cinal A43-6597 or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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): _ Ko5289C

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The intended use of the fourSight ViewTool is for the acceptance, transfer, display, The intendou use of the resing of ultrasound images, including image manipulation and quantification.

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)

David G. Ingram

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

Page __ of ___________________________________________________________________________________________________________________________________________________________________

(Posted November 13, 2003)