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 Description

AI/ML Overview

This FDA 510(k) clearance letter pertains to the CARESTREAM Vue PACS system, including its Lesion Management Application. The document itself does not contain specific acceptance criteria or details of a study proving device performance against such criteria.

The letter confirms that the FDA has reviewed the premarket notification and found the device substantially equivalent to legally marketed predicate devices. This means that, based on the information provided by the manufacturer, the FDA believes the device is as safe and effective as a device already on the market.

Information NOT present in the provided document:

The provided document (an FDA 510(k) clearance letter) does not include any of the requested information regarding acceptance criteria, device performance results, study design, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Explanation of the document's content:

Page 0 & 1: These pages are the official FDA clearance letter. They state:
- The device name: CARESTREAM Vue PACS.
- Regulation Number and Name: 21 CFR 892.2050, Picture archiving and communications system.
- Regulatory Class: II.
- Product Code: LLZ.
- The crucial statement that the device is "substantially equivalent" to legally marketed predicate devices. This equivalence is the basis for its clearance, not a new performance study proving acceptance criteria.
- General regulatory requirements for devices.
Page 2: This page outlines the "Indications for Use" for the CARESTREAM Vue PACS, including the Lesion Management Application.
- The PACS system is intended for archiving, distributing, retrieving, and displaying images and data from hospital modalities.
- The Lesion Management Application is described as a module 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."
- Crucially, it explicitly states: "Lesion Management Application is not to be used for mammography."
- It also confirms that it is a prescription-use device.

To answer your request, one would need to refer to the original 510(k) submission document (K122523) filed by Carestream Health, Inc., which would contain detailed information on performance testing, comparison to predicate devices, and any specific acceptance criteria used for that comparison. The clearance letter itself is the FDA's decision based on that submission, not the submission's content.

Summary

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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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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:

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

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).