CARESTREAM VUE PACS

K122523 · Carestream Health, Inc. · LLZ · Oct 23, 2012 · Radiology

Device Facts

• Record ID: K122523
• Device Name: CARESTREAM VUE PACS
• Applicant: Carestream Health, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Oct 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The CARESTREAM Vue PACS is an image management system whose 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. The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates the review, dictation and reporting tools that creates a productive work environment for the radiologists and physicians. The Lesion Management Application is a module that works with CARESTREAM Vue PACS for measurement of lesions or regions of interest identified by trained users; tabulation of measurements, categorization of tumor response in accordance with user-selected standards, and follow-up record of findings. Lesion Management Application is not to be used for mammography.

Device Story

CARESTREAM Vue PACS is an image management system for hospitals/institutions. It archives, distributes, retrieves, and displays medical images/data from various modalities. The system integrates review, dictation, and reporting tools to support radiologist/physician workflows. It includes a Lesion Management Application module for measuring lesions or regions of interest, tabulating measurements, and tracking tumor response based on user-selected standards. The system provides interactive tools for 3D image analysis and comparison. It is intended for use by trained clinicians to facilitate clinical decision-making through efficient image review and follow-up record keeping.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

PACS software for image management, distribution, and 3D analysis. Includes Lesion Management Application module. Operates on networked hospital infrastructure. Software-based image processing and data management.

Indications for Use

Indicated for hospital and institutional use for archiving, distributing, retrieving, and displaying medical images and data from all modalities. Includes a Lesion Management Application for measuring lesions/regions of interest, tabulating measurements, and categorizing tumor response. Contraindicated for mammography.

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).

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

# 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

OCT
23
2012

Ms. Alexandra Chamberlain Regulatory Affairs Manager Carestream Health, Inc. 150 Verona Street ROCHESTER NY 14608

Re: K122523

Trade/Device Name: CARESTREAM Vue PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 17, 2012 Received: August 20, 2012

Dear Ms. Chamberlain:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, 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 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 Parts 801 and 809); medical device reporting (reporting 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(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 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, anine M. Morris

Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

## 510(k) Number (if known): K122523

### Device Name: CARESTREAM Vue PACS

### Indications for Use:

The CARESTREAM Vue PACS is an image management system whose 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.

The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates the review, dictation and reporting tools that creates a productive work environment for the radiologists and physicians.

The Lesion Management Application is a module that works with CARESTREAM Vue PACS for measurement of lesions or regions of interest identified by trained users; tabulation of measurements, categorization of tumor response in accordance with user-selected standards, and follow-up record of findings. Lesion Management Application is not to be used for mammography.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Muhtul D Othm
(Division Sign Off)

**Division of Radiological Health**

Office of In Vitro Diagnostics and Rad

510(k) K122523

TITLE: Indications for Use Statement PART #: 6K4348 VERSION # 2.0

Unrestricted Internal Use (U) PAGE 1 of 1