(81 days)
Not Found
No
The document describes a medical image viewer and processing system, but there is no mention of AI or ML capabilities in the intended use, device description, or performance studies sections. The processing mentioned refers to displaying and manipulating images, not AI-driven analysis.
No.
The device is a medical image viewer for diagnostic purposes, not a device that provides therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The device may be used to provide images for diagnostic purposes by trained professionals," and the "Device Description" section reiterates this by stating it is "intended for ... diagnostic interpretation."
Yes
The device is explicitly described as a "medical software system" and an "HTML 5 based viewer which runs within a compatible web browser." It states it is "only for use with off the shelf hardware technology that meets defined minimum specifications," indicating it does not include proprietary hardware.
Based on the provided text, the Centricity Universal Viewer Zero Footprint client is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The text explicitly states that this device "displays medical images, data from various imaging sources, and other healthcare information sources." It focuses on viewing and processing images and data, not analyzing biological samples.
- The intended use is for viewing and interpreting medical images for diagnostic purposes. This falls under the category of medical imaging software, not in vitro diagnostics.
- The device description reinforces this. It describes a viewer for accessing and reviewing images stored in PACS and other archives.
Therefore, while it is a medical device used for diagnosis, it operates on medical images and data, not on in vitro specimens.
N/A
Intended Use / Indications for Use
Centricity Universal Viewer Zero Footprint client is a device that displays medical images, data from various imaging sources, and other healthcare information sources. Medical images and data can be viewed, communicated, processed and displayed within a computer network or on a workstation. The device may be used to provide images for diagnostic purposes by trained professionals.
Typical users of this system are authorized individuals and trained healthcare professionals who view medical images and data.
Mammographic images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies.
Contraindications:
Centricity Universal Viewer Zero Footprint client is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Centricity Universal Viewer Zero Footprint client (ZFP) is a medical software system that is intended for multiple users to remotely access the images stored in a compatible Picture Archiving and Communication System, from compatible computers or workstations on a network, for the purpose of review, diagnostic interpretation and post-diagnostic review of medical images and reports.
ZFP is a viewer that does not produce any original medical images nor does it alter any images or medical data. Specifically, ZFP is an HTML 5 based viewer which runs within a compatible web browser and supports secure transmission of data.
ZFP operates within an operating environment that meets defined minimum specifications (see Section 11.1 for Hardware Description). Both the client and server software of ZFP are only for use with off the shelf hardware technology that meets defined minimum specifications.
ZFP can access data created in multiple systems when stored in Centricity™ Clinical Archive solution and Centricity PACS. Additionally, ZFP can access data from any DICOM compliant archive using Enterprise Archive for query retrieve and data moves.
Authorized users can use the diagnostic quality images for diagnostic purposes. These Authorized users include but are not limited to physicians, radiologists, nurses, medical technicians, and assistants.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical images, data from various imaging sources
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this system are authorized individuals and trained healthcare professionals who view medical images and data. These Authorized users include but are not limited to physicians, radiologists, nurses, medical technicians, and assistants.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket notification submission, Centricity Universal Viewer Zero Footprint client, did not require clinical studies to support substantial equivalence.
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.
K123174 - GE Healthcare Centricity PACS-IW with Universal Viewer
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).
0
GE Health 510(k) Premarket Notification Submission Centricity Universal Viewer Zero Footprint client Section 5: 510(k) Summary
2013
510k Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Original filing on June 24th, 2013 Date: Supplemental Information on September 3rd, 2013
Submitter: GE Healthcare 540 West Northwest Highway Barrington, IL 60010
Primary Contact Person:
Nicole Landreville Regulatory Affairs Manager GE Healthcare Phone: 289-208-2365 Fax: 847-277-4506
Secondary Contact Person:
Cheryl Bork Regulatory Affairs Manager GE Healthcare Phone: 847-277-6038 Fax: 847-277-5240
Device Trade Name: Centricity Universal Viewer Zero Footprint client
Picture Archiving and Communication System Common/Usual Name:
Classification Names: 21 CFR 892.2050, System, Image Processing, Radiological
Product Code: LLZ
Predicate Device: K123174 - GE Healthcare Centricity PACS-IW with Universal Viewer
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white.
· Device Description: Centricity Universal Viewer Zero Footprint client (ZFP) is a medical software system that is intended for multiple users to remotely access the images stored in a compatible Picture Archiving and Communication System, from compatible computers or workstations on a network, for the purpose of review, diagnostic interpretation and post-diagnostic review of medical images and reports.
ZFP is a viewer that does not produce any original medical images nor does it alter any images or medical data. Specifically, ZFP is an HTML 5 based viewer which runs within a compatible web browser and supports secure transmission of data.
ZFP operates within an operating environment that meets defined minimum specifications (see Section 11.1 for Hardware Description). Both the client and server software of ZFP are only for use with off the shelf hardware technology that meets defined minimum specifications.
ZFP can access data created in multiple systems when stored in Centricity™ Clinical Archive solution and Centricity PACS. Additionally, ZFP can access data from any DICOM compliant archive using Enterprise Archive for query retrieve and data moves.
Authorized users can use the diagnostic quality images for diagnostic purposes. These Authorized users include but are not limited to physicians, radiologists, nurses, medical technicians, and assistants.
2
Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are black, while the background is white.
Intended Use: Centricity Universal Viewer Zero Footprint client is a device that displays medical images, data from various imaging sources, and other healthcare information sources. Medical images and data can be viewed, communicated, processed and displayed within a computer network or on a workstation. The device may be used to provide images for diagnostic purposes by trained professionals.
Typical users of this system are authorized individuals and trained healthcare professionals who view medical images and data.
Mammographic images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies.
Contraindications:
Centricity Universal Viewer Zero Footprint client is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Discussion regarding the modifications to the Intended Use / Indications ・
for Use
The Intended Use / Indications for Use statement was modified from the Predicate device to clarify the following:
The Subject Device, ZFP, is designed to display medical images, data from various imaging sources and other healthcare information sources while Centricity PACS-IW with Universal Viewer Web Client v.5.0 is designed for a broader set of functions, which include the storage of images and data, the communication of images and data as well as the processing of images and data.
To clarify the conditions regarding appropriate diagnostic usage. The verbiage was clarified to explicitly describe that for mammographic images the user needs to use monitors compliant with requirements of local regulations as regulated by the local regulatory agencies (such as FDA). The use of lossy compressed images is now stated in a separate contraindications statement to raise the importance of using the appropriate type of mammographic images to support primary image interpretations.
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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.
Discussion regarding the modifications to the Intended Use / Indications for Use (con't) The ZFP's Intended Use / Indications for Use statement contains a subset of the predicate device's Intended Use / Indications for Use. These modifications do not impact the equivalence to the predicate in terms of intended use. Specific differences between the Predicate and the Subject device are included in the Section 12: Substantial Equivalence.
Technology: Centricity Universal Viewer Zero Footprint client displays medical images and other information from various data sources. The information can be processed and displayed across computer networks at dispersed locations.
ZFP is a software-only device that runs on commercially available off-the-shelf computer hardware platforms.
The ZFP device employs the same fundamental scientific technology as its predicate device, Centricity PACS-IW with Universal Viewer with Zero Footprint as an option cleared under K123174, with the following modifications:
-
- ZFP now provides compatibility with Centricity PACS.
-
- New ZFP enhancements provide support for the following:
- Side-by-side Comparison .
- Patient level inbound URL launch .
- Secure Inbound URL token authentication .
- Internet Explorer 7 & 8 support via Google . Chrome Frame
- Internet Explorer 9 & 10 support t
- Safari, Firefox support ●
- Localizable multiple date format ●
- UTF-16 Character Encoding Scheme �
- Up to 4 multi-frame cine running in parallel .
- Zoom and pan during cine .
- ZFP may now be accessed from an iPad with internet 3. access. When accessed from the Apple® iPad®, ZFP can only be used in review only mode and is not meant for primary diagnosis. Other mobile devices. smartphones and tablets have not been validated.
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are in black, creating a strong contrast against the white background. The logo is a well-known symbol associated with the General Electric company.
GE Healtha 510(k) Premarket Notification Submission Centricity Universal Viewer Zero Footprint client Section 5: 510(k) Summary
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests
The software documentation was provided at a moderate level of concern following the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Universal Viewer ZFP client complies with voluntary standards as detailed in this premarket notification submission (Refer to Section 9 - Declaration of Conformity and Summary Reports).
The following quality assurance measures were applied to the development of the system:
- Risk Analysis .
- Requirements Reviews .
- Design Reviews .
- Usability Analysis .
- Testing on unit level (Verification) .
- Integration testing (Verification) .
- Regression testing (Verification) .
- System testing (Verification) .
- Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket notification submission, Centricity Universal Viewer Zero Footprint client, did not require clinical studies to support substantial equivalence.
Conclusion:
Comparison of the Intended Uses / Indications for Use, the technological characteristics, and performance specifications demonstrate the functional equivalence of the subject device to the predicate device.
Verification and Validation testing results demonstrate that no adverse effects have been introduced by these differences.
The Centricity Universal Viewer Zero Footprint client device will continue to have an intended use and functionality fitting within the definition of 21 CFR 892.2050, Picture Archiving and Communication Systems, Product Code LLZ.
Information provided in this premarket notification submission supports the Centricity Universal Viewer Zero Footprint client medical device to be as safe, as effective and substantially equivalent to its predicate device.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three parallel lines that curve and resemble a stylized human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is oriented to follow the curve of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 17, 2013
GE Healthcare % Ms Nicole Landreville Regulatory Intelligence Manager 540 West Northwest Highway BARRINGTON IL 60010
Re: K131977
Trade/Device Name: Centricity Universal Viewer Zero Footprint client Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 4, 2013 Received: September 6, 2013
Dear Ms. Landreville:
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. 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 complics 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 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.
6
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/ResourcesforYou/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/Industrv/default.htm.
Sincerely yours.
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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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Indications for Use
510(k) Number (if known): K131977
Device Name: Centricity Universal Viewer Zero Footprint client
Indications for Use:
Centricity Universal Viewer Zero Footprint client is a device that displays medical images, data from various imaging sources, and other healthcare information sources. Medical images and data can be viewed, communicated, processed and displayed within a computer network or on a workstation. The device may be used to provide images for diagnostic purposes by trained professionals.
Typical users of this system are authorized individuals and trained healthcare professionals who view medical images and data.
Mammographic images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies.
Contraindications:
Centricity Universal Viewer Zero Footprint client is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Prescription Use X (Part 21 CFR 801 Subpart D) 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 Diagnostics and Radiological Health (OIR)
$m_{h}p).
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k)
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