KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB

K030781 · Eastman Kodak Company · LLZ · May 29, 2003 · Radiology

Device Facts

• Record ID: K030781
• Device Name: KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB
• Applicant: Eastman Kodak Company
• Product Code: LLZ · Radiology
• Decision Date: May 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

Eastman Kodak DirectView PACS/Image Management System(DV PACS) intended use is to provide completely scaleable image/data management solutions for hospital and related institutions/sites including, at a minimum, local to wide area primary diagnostic workstations to enterprise storage centers. DV PACS also provides services that will allow remote sites to have access to diagnostic image/patient data through industry standard interfaces, including web browsers supported by Eastman Kodak and other's predicate devices. DV PACS is designed using an open architecture that allows various proprietary and off the shelf (OTF) software integrated with OTF hardware components to be configured to meet the user's specific needs. Using DICOM and other industry standards, DirectView PACS archives/ distributes/retrieves and displays images and data from all hospital modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), mammography, cardio systems, digitized X-ray films, digital angiography, and fluoroscopy as well as all hospital/radiology information systems.

Device Story

Kodak DirectView PACS is a scalable image and data management system for hospitals and clinical institutions. It ingests medical images and patient data from diverse modalities—including CT, MRI, Ultrasound, CR, DR, Nuclear Medicine, mammography, and digital angiography—as well as hospital and radiology information systems. The system utilizes an open architecture, integrating proprietary and off-the-shelf software and hardware to archive, distribute, retrieve, and display diagnostic data. It supports local and wide-area networks, enabling remote access via industry-standard interfaces and web browsers. Operated by radiologists and clinicians, the system provides diagnostic-quality visualization at primary workstations. By centralizing image management and facilitating efficient data retrieval, the device supports clinical decision-making and workflow optimization across the enterprise.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on feature comparison and functional demonstration.

Technological Characteristics

Open architecture system integrating off-the-shelf hardware and software. Utilizes DICOM and industry-standard interfaces for connectivity. Supports local and wide-area network configurations. Designed for enterprise-level image archiving, distribution, and diagnostic display.

Indications for Use

Indicated for use in hospital and clinical settings to archive, distribute, retrieve, and display medical images and data from various modalities (CT, MRI, US, CR, DR, NM, mammography, cardio, digital angiography, fluoroscopy) and information systems. For use by healthcare 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

• AccuRad
• Archive Manager

Submission Summary (Full Text)

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MAY 2 9 2003

#### 510(k) Summary 6.1

### 1. Company Identification

Eastman Kodak Company 343 State Street Rochester, NY 14650

#### 2. Contact Person

Linda J. Moore, Dir.of Regulatory Affairs, HCIS Products Eastman Kodak Health Imaging 47315 Mission Falls Ct. Fremont, CA 94539 510-770-5456 Fax. [phone] [e-mail]

#### 3. 510(k) Summary Preparation Date

March 7, 2003

#### 4. Device Name

Kodak DirectView PACS/Image Management Systems

#### 5. Device Classification

Class II

#### 6. Intended Use/Device Description

Eastman Kodak DirectView PACS/Image Management System(DV PACS) intended use is to provide completely scaleable image/data management solutions for hospital and related institutions/sites including, at a minimum, local to wide area primary diagnostic workstations to enterprise storage centers. DV PACS also provides services that will allow remote sites to have access to diagnostic image/patient data through industry standard interfaces, including web browsers supported by Eastman Kodak and other's predicate devices. DV PACS is designed using an open architecture that allows various proprietary and off the shelf (OTF) software integrated with OTF hardware components to be configured to meet the user's specific needs. Using DICOM and other industry standards, DirectView PACS archives/ distributes/retrieves and displays images and data from all hospital modalities including but not limited to, CT, MRI, Ultrasound

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(US), CR, DR, Nuclear Medicine (NM), mammography, cardio systems, digitized X-ray films, digital angiography, and fluoroscopy as well as all hospital/radiology information systems.

## 7. Substantial Equivalence Summary

The DirectView PACS/Image Management System is substantially equivalent in design and intended use to diagnostic radiological workstations, PACS and image management systems as substantiated in the feature comparison. The comparison listed in Section 3.3 clearly demonstrates that DirectView PACS/Image Management System is substantially equivalent in all areas such as functionality, user/software features, hardware components and connectivity. Although, the comparison only lists DirectView PACS equivalence to its predecessors. AccuRad and Archive Manager, the stated indications for use, listed on the comparison, does show substantial equivalence to other manufacturer's industry standard PACS/image management systems. Therefore, DirectView PACS raises no new issues of safety or effectiveness from its predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2003

Ms. Linda J. Moore Director, Regulatory Affairs, HCIS Products Eastman Kodak Company 47315 Mission Falls Ct. FREMONT CA 94539

Re: K030781

Trade/Device Name: Kodak DirectView PACS/Image Management System Regulation Number: 21 CFR \$892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: March 7, 2003 Received: March 11, 2003

Dear Ms. Moore:

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 | [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" (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,

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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# 6.2 FDA Indications for Use

510K # K03078|

Device Name: Kodak DirectView PACS/Image Management System

The Kodak DirectView PACS is an image management system whose Indications for Use: intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive/ distribute/ retrieve and display images and data from all hospital modalities and information systems.

| | Concurrence of CDRH, Office of Device Evaluation |
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Prescription Use (Per 21 CFR 801.109)

OR

Over - The - Counter _________________________________________________________________________________________________________________________________________________________

David R. Bergman