CARESTREAM IMAGE SUITE

K100094 · Carestream Heatlh, Inc. · LLZ · Mar 11, 2010 · Radiology

Device Facts

• Record ID: K100094
• Device Name: CARESTREAM IMAGE SUITE
• Applicant: Carestream Heatlh, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Mar 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

CARESTREAM Image Suite is an image management system whose intended use is to receive, process, review, display, print and archive images and data from all imaging modalities. This excludes mammography applications in the United States.

Device Story

CARESTREAM Image Suite is a stand-alone, hardware-independent radiographic imaging system for small clinics. It manages medical images, reports, patient/exam information, and workflow. Input data is acquired from CR and DR modalities (e.g., DirectView Classic CR, Point-of-Care 140/145/360 CR). The system processes, reviews, archives, and prints images and reports on a PC workstation. It utilizes existing KODAK Eclipse Image Processing Software for image processing modules. The system is designed for intuitive use by clinic staff. Output is displayed on monitors for healthcare providers to assist in clinical review and reporting. Benefits include a low-cost, integrated platform for managing diagnostic imaging workflow.

Clinical Evidence

Bench testing only. Performance testing was conducted to verify design output met design input requirements and to validate the device conformed to defined user needs. Nonclinical testing was performed under simulated use conditions. Predefined acceptance criteria were met.

Technological Characteristics

Hardware-independent system designed to run on a PC workstation. Integrates with CR and DR modalities. Utilizes KODAK Eclipse Image Processing Software modules. Supports web registration, web viewer, report generation, CD export, and long-term image storage. Connectivity includes interfacing with Carestream Health and 3rd party PACS systems.

Indications for Use

Indicated for use as an image management system to receive, process, review, display, print, and archive images and data from CR and DR imaging modalities. Excludes mammography applications in the United States.

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

• CARESTREAM PACS V11 (K083673)
• Kodak Eclipse Image Processing Software (K060137)

Submission Summary (Full Text)

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K100097
Traditional 510(k): Carestream Health, Inc.

# "510(k) Summary"

MAR ] 1 2010

510(k) Owner Name

510(k) Owner Address

510(k) Owner Phone

510(k) Owner Fax

Contact Name & Info

Date Summary Prepared

Device Common Name -

Device Trade Name

Classification Name

Regulation Name

Regulation Number

Predicate Device

Device Class

Device Code

. "

Carestream Health, Inc.

150 Verona Street Rochester, New York 14608

585 627-6543

585 454-1894

John Pardo Director, Regulatory Affairs and Quality Systems

[e-mail]

January 5, 2010

CARESTREAM Image Suite

CARESTREAM Image Suite

System, Image Processing, Radiological

Picture Archiving and Communication System

Class II

LLZ

21 CFR 892.2050, Picture Archiving and Communications System

K083673 - Device Name: CARESTREAM PACS V11

K060137 - Device Name: Kodak Eclipse Image Processing Software

### Device Description

CARESTREAM Image Suite is a stand-alone, self-contained radiographic imaging system designed to provide a low-cost platform to manage medical images, reports, patient/exam information and workflow in small clinics. The system performs capture, processing, review, archiving, and printing of radiographic images as well as report writing and printing and is designed to run on a PC workstation. The CARESTREAM Image Suite is designed to be simple and intuitive to both use and service.

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#### CARESTREAM Image Suite

CARESTREAM Image Suite is designed as a hardware-independent system and may be interfaced with verified and validated image acquisition devices from both Carestream Health and 3rd party vendors, Carestream Health PACS system, and other 3rd party PACS systems. The system will acquire an image from either a DirectView Classic CR or a Point-of-Care 140/145 or 360 CR and be PC and monitor independent.

#### Intended Use

The CARESTREAM Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States.

#### Comparison of Technological Characteristics

The subject device and predicate devices use the same technical design base. The CARESTREAM Image Suite supports web registration, web viewer, PoC and Classic CR scanner integration, report, CD export, image processing and long term image storage. The design is based on current Carestream technology with the image processing modules using the existing KODAK Eclipse Image Processing Software product without any modifications to the software responsible for image processing.

#### Discussion of Testing

Performance testing was conducted to verify the design output met the design input requirements and to validate the device conformed to the defined user needs and intended uses. Nonclinical testing was conducted under simulated use conditions. Predefined acceptance criteria was met and demonstrated that the device is as safe and as effective as the predicate devices.

TITLE: 510(k) Summary CARESTREAM Image Suite PART #: 8H9822 VERSION: 1.0

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002

### MAR 1 1 2010

Mr. John Pardo Director, Regulatory Affairs and Quality Systems Carestream Health, Inc. 150 Verona Street ROCHESTER NY 14608

Re: K100094

Trade/Device Name: CARESTREAM Image Suite Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 3, 2010 Received: March 4, 2010

Dear Mr. Pardo:

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, Or to 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, ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Cittle 20. Code of Federal Regulations (CFR), Parts 800 to 895. 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 aft 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 Parts 801 and 809); medical device reporting (reportions of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(l), rems ket 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 dryice to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

| 510(k) Number (if known): | K100094 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | CARESTREAM Image Suite |
| Indications for Use: | CARESTREAM Image Suite is an image management system whose intended use is to receive, process, review, display, print and archive images and data from all imaging modalities. This excludes mammography applications in the United States. |

Prescription Use X (Part 21 CFR 801 Subpart D)

510K.

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 In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of ____________________________________________________________________________________________________________________________________________________________________