(57 days)
Not Found
No
The document describes standard image management and viewing software with basic tools, and there is no mention of AI or ML capabilities.
No
The document describes a medical image management system and viewing software used for accessing patient data, reports, and images, which are tools for diagnosis and review, not a direct therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device 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." Moreover, the "Summary of Performance Studies" explicitly states that the "Tablet Viewer Software for Image Suite is suitable as a platform to display patient data, medical reports, and medical images for diagnosis from different modalities." This indicates its role in the diagnostic process.
Yes
The device description explicitly states "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." While it runs on a tablet, the submission focuses on the software component and its functionality as an extension of the existing Image Suite system. The hardware (iPad 2) is mentioned as the platform, but the device being cleared is the software itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that the CARESTREAM Image Suite and its Tablet Viewer Software are image management systems. Their purpose is to receive, process, review, display, print, and archive medical images and data from various imaging modalities (CR, DR, CT, MR, US).
- No mention of biological samples: There is no indication in the text that this device interacts with or analyzes biological samples from patients. Its function is solely related to the handling and display of medical images and associated data.
Therefore, based on the provided information, this device falls under the category of medical imaging software and systems, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, DR, CT, MR, and US.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Results of bench and clinical testing demonstrated that the Tablet Viewer 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
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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 |
| Rochester, New York 14608 | |
| 510(k) Owner Phone: | 585-627-8790 |
| 510(k) Owner Fax: | 585-323-7643 |
| Contact Name & Info: | Alexandra Chamberlain |
| Requlatory Affairs Manager | |
| alexandra.chamberlain@carestream.com | |
| 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 |
| Manufactured by Carestream Health, Inc. | |
| 510(k) Number - K100094 (March 11, 2010) |
1
Image /page/1/Picture/0 description: The image shows the word "Carestream" in a stylized font. The letters are outlined in black, giving them a distinct appearance. The font choice adds a unique visual element to the word, making it stand out.
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
2
Image /page/2/Picture/0 description: The image shows the word "Carestream" in a simple, sans-serif font. The letters are outlined in black, giving them a slightly bold appearance. The word is presented in a straightforward, horizontal arrangement.
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.
3
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.
4
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
5
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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