TABLET VIEWER SOFTWARE FOR IMAGE SUITE

K140271 · Carestream Health, Inc. · LLZ · Apr 1, 2014 · Radiology

Device Facts

• Record ID: K140271
• Device Name: TABLET VIEWER SOFTWARE FOR IMAGE SUITE
• Applicant: Carestream Health, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Apr 1, 2014
• 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. Tablet Viewer Software for Image Suite is used for patient management by clinicians in order to access and display patient data, medical reports, and medical images for diagnosis from different modalities including CR, DR, CT, MR, and US. Tablet Viewer Software for Image Suite provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. This device is not intended to replace the full Mini-PACS and should be used only when there is no access to the full Mini-PACS Web Viewer. This excludes mammography applications in the United States.

Device Story

Tablet Viewer Software for Image Suite is an optional extension to the Image Suite Mini-PACS. It enables clinicians to access patient images, reports, and data on an iPad 2 via wireless network. The software utilizes HTML5 to allow browser-enabled mobile devices to function as remote viewers. It provides a GUI for basic image manipulation, including zoom, pan, windowing, basic measurements, and cine. The system is intended for use in small clinics for remote reading or referral purposes when the full Mini-PACS Web Viewer is inaccessible. It does not perform primary diagnostic image processing but facilitates clinical review and decision-making by providing portable access to imaging data.

Clinical Evidence

Clinical assessment performed on the Apple iPad 2 to validate the display of medical images for diagnostic purposes. Bench testing included evaluation of luminance response, viewing angles, resolution, noise, reflectivity, and device settings. Functional QA testing confirmed software performance. No specific sensitivity/specificity metrics were reported; the device was validated for its intended use as a remote viewing platform.

Technological Characteristics

Software-based PACS extension using HTML5 for browser-based access on mobile devices (iPad 2). DICOM compliant. Features include zoom, pan, windowing, measurements, and cine. Validated for display performance (luminance, resolution, reflectivity).

Indications for Use

Indicated for clinicians to access and display patient data, medical reports, and medical images for diagnosis from CR, DR, CT, MR, and US modalities. Used for remote reading or referral via web browsers on validated mobile devices. Not for mammography applications in the US. Not intended to replace full Mini-PACS.

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

• Image Suite (K100094)

Submission Summary (Full Text)

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# APR 0 1 2014

K140271
Page 1 of 3

Carestream

Carestream Health Inc. 150 Verona Street Rochester, NY 14608

# 510(k) Summary Pursuant to 21 CFR 807.92

| 510{k) Owner Name: | Carestream Health, Inc. |
|------------------------|-------------------------------------------------------------------------------------------------------------|
| 510{k} Owner Address: | 150 Verona Street<br>Rochester, New York 14608 |
| 510(k) Owner Phone: | 585-627-8790 |
| 510(k) Owner Fax: | 585-323-7643 |
| Contact Name & Info: | Alexandra Chamberlain<br>Requlatory Affairs Manager<br>[e-mail]<br>585-627-8790 |
| Date Summary Prepared: | January 31, 2014 |
| Device Trade Name: | Tablet Viewer Software for Image Suite |
| Device Common Name: | PACS |
| Classification Name: | System, Image Processing, Radiological |
| Regulation Name: | Picture Archiving and Communication System |
| Device Class: | Class II |
| Device Code: | LLZ |
| Regulation Number: | 21 CFR 892.2050 |
| Predicate Device: | Image Suite<br>Manufactured by Carestream Health, Inc.<br>510(k) Number - K100094 (March 11, 2010) |

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Carestream Health Inc. 150 Verona Street Rochester, NY 14608

### Device Description:

CARESTREAM Tablet Viewer Software for Image Suite is an optional feature for Image Suite Mini-PACS users. The software technology uses HTML5 which allows a browserenabled mobile device to run the software application. The user is able to access patient images and study reports from an iPad 2 mobile device anywhere through a wireless network. Tablet Viewer Software for Image Suite has a simple GUI for viewing and includes some fundamental tools such as zoom, pan, windowing, basic measurements, cine, etc. Tablet Viewer Software for Image Suite functions as an extension to Image Suite.

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, archive, and printing of radiographic images as well as report writing and printing and is designed to run on a PC workstation. CARESTREAM Image Suite is designed to be simple and intuitive to both use and service.

CARESTREAM Image Suite connects with hardware including multiple radiographic image capture devices (CR and / or DR detectors) attached to a PC workstation with either a standard or a high-resolution monitor. CARESTREAM Image Suite is designed as a hardware-independent system and may be interfaced with verified and validated imaging modalities from both Carestream Health and 3rd party vendors, as well as Carestream Health PACS systems, and other 3rd party PACS systems. The Image Suite system can directly acquire an image from Carestream Health acquisition devices and is PC and monitor independent.

### 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.

Tablet Viewer Software for Image Suite is used for patient management by clinicians in order to access and display patient data, medical reports, and medical images for diagnosis from different modalities including CR. DR. CT, MR, and US.

Tablet Viewer Software for Image Suite provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. This device is not intended to replace the full Mini-PACS and should be used only when there is no access to the full Mini-PACS Web Viewer.

This excludes mammography applications in the United States.

દર્

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Carestream Health Inc. 150 Verona Street Rochester, NY 14608

## Technological Characteristics:

The Tablet Viewer Software for Image Suite is fully compatible with Image Suite and can be displayed on the iPad 2 mobile device.

The product is software, and has been extensively tested in accordance with General Principles of Software Validation; Final Guidance for Industry and FDA Staff. The product is DICOM Compliant. Testing included the following:

- . Bench testing on the Apple iPad 2 for luminance response, optimal viewing angles, resolution, noise, reflectivity, device and display settings, and exception handling
- A Clinical Assessment of Tablet Viewer Software for Image Suite on the Apple . iPad 2
- . Functional QA testing of the software

The technological characteristics of the new device are equivalent to the predicate device in that they use the same Image Suite PACS platform. The new type of display device is being introduced by the introduction of Tablet Viewer Software for Image Suite.

The Indications of the predicate and subject are similar, differing only by the added description related to the remote access from the validated mobile device and the list of supported modalities for the Tablet Viewer software.

### Substantial Equivalence:

Tablet Viewer Software for Image Suite is a new feature that can be used with Image Suite (predicate device, K100094). The software provides wireless and portable access to medical images for remote reading or referral purposes using an iPad 2 mobile Results of bench and clinical testing demonstrated that the Tablet Viewer device. Software for Image Suite is suitable as a platform to display patient data, medical reports, and medical images for diagnosis from different modalities including CR, DR, CT, MR, and US. No substantial differences that affect safety and efficacy were noted in comparison with the predicate device.

### Conclusion:

CARESTREAM Tablet Viewer Software for Image Suite is substantially equivalent to the CARESTREAM Image Suite predicate. The product has been validated and tested and no substantial differences that affect safety and efficacy were noted.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

#### Public Health Service

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

## April 1, 2014

Carestream Health, Inc. % Ms Alexandra Chamberlain Regulatory Affairs Manager l 50 Verona Street ROCHESTER NY 14608

Re: K140271

Trade/Device Name: Tablet Viewer Software for Image Suite Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 4, 2014 Received: February 5, 2014

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 general connell provision practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 that i Drederal statutes and regulations administered by other Federal agencies. You must or any I odoral statution and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Ms Chamberlain

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh-7)

for

Janine 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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# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

# K140271

Device Name

CARESTREAM Tablet Viewer Software for Image Suite

### Indications for Use (Describe)

CARESTREAM Image Suite is an imagement system whose intended use is to receive, process. review. display, print and archive images and data from all imaging modalities,

Tablet Viewer Software for Image Suite is used for patient management by clinicians in order to access and display patient data. medical reports, and medical images for different modalities including CR. DR. CT. MR, and US.

Tablet Viewer Software for Image Suite provides wireless and portable images for remote reading or referral purposes from web browsers including usage with validated mobile device is not intended to replace the full Mini-PACS and should be used only when there is no access to the full Mini-PACS Web Viewer.

This excludes mammography applications in the United States.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

O Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

# FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Smh.7)

FORM FDA 3881 (9/13)

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