KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

K023772 · Acuson Corp. · LLZ · Nov 22, 2002 · Radiology

Device Facts

• Record ID: K023772
• Device Name: KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Applicant: Acuson Corp.
• Product Code: LLZ · Radiology
• Decision Date: Nov 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The intended use of the KinetD, is for the acceptance, transfer, display, storage, and digital processing of diagnostic ultrasound, CT, MRI, and X-ray angiography images, including manipulation and quantification of the images.

Device Story

KinetDx is a Picture Archival and Communications System (PACS) for clinical image management. It accepts diagnostic images (ultrasound, CT, MRI, X-ray angiography) and associated data from DICOM-compliant acquisition devices via a network. The system consists of a dedicated DICOM server for storage/archiving and networked workstations for clinical review. Physicians and clinicians use workstations to view, manipulate, and quantify images, edit patient demographic/clinical data, and prepare reports. An optional proprietary Dynamic Array Processor (DAP) card in review stations accelerates image decompression and display. The system facilitates clinical decision-making by providing centralized access to diagnostic imaging studies.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

PACS utilizing standard computer hardware and Windows 2000 operating system. Includes optional proprietary Dynamic Array Processor (DAP) card for accelerated image decompression/display. Connectivity via DICOM network. Software-based image processing and management.

Indications for Use

Indicated for the acceptance, transfer, display, storage, and digital processing of diagnostic ultrasound, CT, MRI, and X-ray angiography images, including manipulation and quantification of the images for clinical 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

• EchoLink (K980060)
• ALI UltraPacs (K925965)
• ALI DataComPacs Module (K963610)

Submission Summary (Full Text)

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# K023772

## 510(k) Summary of Safety and Effectiveness

#### Acuson Corporation's KinetDx - Medical Image Management Device

Acuson Corporation has not disclosed its intent to market this device modification and requests this notification be held CONFIDENTIAL by FDA, and not be released to any Freedom of Information request or addressed with any outside parties.

| Sponsor: | Siemens Medical Solutions,<br>Acuson Ultrasound Division<br>1230 Shorebird Way<br>Mountain View, CA 94043 |
|-----------------|-----------------------------------------------------------------------------------------------------------|
| Contact Person: | Bob Leiker<br>Senior Regulatory Affairs Specialist<br>Telephone: [phone]<br>Fax: [phone] |

Submission Date: October 31, 2002

Device Name: KinetDx

Common or Usual Name: Picture Archival and Communications System

#### Classification:

Picture Archival and Communications System (LLZ) class II (21CFR §892.2050)

#### Predicate Device:

EchoLink, K980060 cleared on February 25, 1998 ALI UltraPacs, K925965 cleared on June 14, 1993 ALI DataComPacs Module, K963610, cleared on November 27, 1996

#### Device Description:

KinetDx is a picture archival and communications system (PACS) that includes a dedicated DICOM server used for image and data storage, retrieval, and archiving. The server accepts images and data from DICOM acquisition devices attached to it by way of a network. The system also includes one or more workstations networked with the server, which are used for clinical review of images and data. Workstations also allow editing of patient demographic and clinical data, image manipulation, and preparation of clinician's reports.

#### Intended Use:

The intended use of the KinetD, is for the acceptance, transfer, display, storage, and digital processing of diagnostic ultrasound, CT, MRI, and X-ray angiography images, including manipulation and quantification of the images.

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### Technological Characteristics and Substantial Equivalence:

Similar to the predicate devices, the computer hardware components used for the KinetDx server and review stations are standard computer hardware procured from qualified vendors, with the exception of an optional proprietary card available for review stations. This optional card, the KinetDx Dynamic Array Processor (DAP) card, provides faster decompression and display of image data than can be provided using regular system memory. The KinetDx server and review stations use proprietary software to accomplish their functions. Servers and review stations use the Windows2000 operating system.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Rockville MD 208

# 2.2. 2007

Acuson Corporation % Mr. Mark Job : 510(K) Program Manager TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K023772

Trade/Device Name: KinetDx Picture Archiving and Communications System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ Dated: November 8, 2002 Received: November 12, 2002

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 (PMA), it may be subject to 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 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:

| 8xx.1xxx | (301) 594-459 |
|----------------------------------|---------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-461 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-461 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-465 |
| Other | (301) 594-469 |

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" (21 CFR Part 807.97). 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,

Henry 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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KUL 3772

Incintended use of the KinetDy Indications For Use
The intended use of the KinetDy, is for the acceptance, display, storage, and digital processing of diagnostic ultrasound, CT, MRI, and X-ray angiography images, including manipulation and quantification of the images.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Legum

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

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