(97 days)
No
The document describes image display, processing, and integration capabilities but does not mention AI, ML, or related terms.
No
The device is described as an image display and interpretation software product that assists in diagnostic workflows, not a device that directly administers therapy or performs a therapeutic function.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information." The "Device Description" section also mentions that it "assists radiologists and cardiologists in their diagnostic workflows."
Yes
The device description explicitly states "Centricity Universal Viewer is an Internet based medical image display and interpretation software product". While it integrates with other medical devices and utilizes commercial computer platforms, the core device being described and submitted is the software itself. The description focuses on software functionalities like display, communication, storage, and processing of images.
Based on the provided text, the Centricity Universal Viewer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Centricity Universal Viewer's Function: The description clearly states that the Centricity Universal Viewer displays, communicates, stores, and processes medical images and data from various imaging sources. It does not involve the analysis of specimens taken from the human body.
- Input: The input modalities are imaging modalities (CT, MR, Ultrasound, etc.), not biological specimens.
- Intended Use: The intended use is to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information, not to analyze biological samples.
Therefore, the Centricity Universal Viewer falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS) component, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed.
Typical users of this system are authorized healthcare professionals.
Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Mammography 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 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 is an Internet based medical image display and interpretation software product that is part of a picture archiving and communications system that assists radiologists and cardiologists in their diagnostic workflows. It provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms).
Centricity Universal Viewer provides APIs (Application Program Interfaces) to integrate with third-party medical devices and non-medical devices, which include integration with Tomtec-Arena™(K132544) for advanced cardiology applications.
Centricity Universal Viewer supports DICOM SOP classes to access and manage medical imaging studies from , Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Nuclear Medicine (NM), Computerized Radiography (CR), Digital mammography (MG), Digital X-ray (DX), Positron Emission Tomography (PET/PT), X-Ray Angioaraphy (XA), Diaital Intra-oral X-Ray (IO), Radiofluoroscopic X-ray (RF), Secondary Capture Images (SC), Visible Light (VL) Endoscopic, Microscopic and Photographic Image Storage, Slide Coordinates Microscopic Image Storage, Presentation States (PS), Key Image Notes (KIN), and other DICOM imaging modalities.
Centricity Universal Viewer is not intended for the diagnosis of digital pathology images.
Centricity Universal Viewer is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms and operating systems.
The system does not produce any original medical images. All images located on the Centricity Universal Viewer have been received from DICOM compliant modalities and/or image acquisition systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Nuclear Medicine (NM), Computerized Radiography (CR), Digital mammography (MG), Digital X-ray (DX), Positron Emission Tomography (PET/PT), X-Ray Angioaraphy (XA), Diaital Intra-oral X-Ray (IO), Radiofluoroscopic X-ray (RF), Secondary Capture Images (SC), Visible Light (VL) Endoscopic, Microscopic and Photographic Image Storage, Slide Coordinates Microscopic Image Storage, Presentation States (PS), Key Image Notes (KIN), and other DICOM imaging modalities.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
authorized healthcare professionals.
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 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".
Centricity Universal Viewer complies with voluntary standards as detailed in this premarket notification submission.
The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Usabilitv Analvsis
- Testing on unit level (Verification)
- Integration testing (Verification)
- Performance testing (Verification)
- Regression testing (Verification)
- System testing (Verification)
- Simulated use testing (Validation)
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2015
GE Healthcare % Ms. Cheryl Bork Regulatory Affairs Manager 540 W. Northwest Highway BARRINGTON IL 60010
Re: K150420
Trade/Device Name: Centricity Universal Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 13, 2015 Received: April 15, 2015
Dear Ms. Bork:
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 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 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (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 Industry and Consumer Education 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,
Robert A Ochs
Robert Ochs. Ph.D. Acting 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) K150420
Device Name
Centricity Universal Viewer
Indications for Use (Describe)
Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed.
Typical users of this system are authorized healthcare professionals.
Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Mammography 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 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
l. SUBMITTER
GE Healthcare 540 West Northwest Highway Barrington, IL 60010
| Primary Contact Person: | Cheryl Bork |
|---|---|
| Regulatory Affairs Manager | |
| GE Healthcare | |
| Phone: 847-277-6038 | |
| Fax: 847-277-5240 |
| Secondary Contact Person: | Jason Ma
Regulatory Affairs
GE Healthcare
Phone: 847-277-4325
Fax: 847-277-5240 |
| --------------------------- | --------------------------------------------------------------------------------------------- |
|---|
Date Prepared: May 21, 2015
II. DEVICE
| Name of Device: | Centricity Universal Viewer |
|---|---|
| Common Name: | Picture Archiving and Communication System |
| Classification Name: | 21 CFR 892.2050, System, Image Processing, |
| Radiological | |
| Regulatory Class: | II |
| Product Code: | LLZ |
III. PREDICATE DEVICE
K123174 - GE Healthcare Centricity PACS-IW with Universal Viewer This predicate device was subject to ONE design-related recall in Oct-13-2013. However, this performance issue has been reviewed and mitigated. A detailed description can be found in Section 21. Total Product Life Cycle (TPLC).
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IV. DEVICE DESCRIPTION
Centricity Universal Viewer is an Internet based medical image display and interpretation software product that is part of a picture archiving and communications system that assists radiologists and cardiologists in their diagnostic workflows. It provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms).
Centricity Universal Viewer provides APIs (Application Program Interfaces) to integrate with third-party medical devices and non-medical devices, which include integration with Tomtec-Arena™(K132544) for advanced cardiology applications.
Centricity Universal Viewer supports DICOM SOP classes to access and manage medical imaging studies from , Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Nuclear Medicine (NM), Computerized Radiography (CR), Digital mammography (MG), Digital X-ray (DX), Positron Emission Tomography (PET/PT), X-Ray Angioaraphy (XA), Diaital Intra-oral X-Ray (IO), Radiofluoroscopic X-ray (RF), Secondary Capture Images (SC), Visible Light (VL) Endoscopic, Microscopic and Photographic Image Storage, Slide Coordinates Microscopic Image Storage, Presentation States (PS), Key Image Notes (KIN), and other DICOM imaging modalities.
Centricity Universal Viewer is not intended for the diagnosis of digital pathology images.
Centricity Universal Viewer is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms and operating systems.
The system does not produce any original medical images. All images located on the Centricity Universal Viewer have been received from DICOM compliant modalities and/or image acquisition systems.
5
V. INDICATIONS FOR USE
Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed.
Tvpical users of this svstem are authorized healthcare professionals.
Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Mammography 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 requlatory agencies.
Contraindications:
Centricity Universal Viewer 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Centricity Universal Viewer device emplovs the same fundamental scientific technology as its predicate device, Centricity PACS-IW with Universal Viewer cleared under K123174, with the following modifications:
- . Expanding the capabilities of Centricity Universal Viewer for Cardiology in addition to Radiology applications.
- . Modified viewer to present a common unified workspace for radiologists, cardiologists and clinicians to perform the review, manipulation and diagnostic interpretation of images and other information generated by acquisition.
- . Hardware specifications minimum specifications were modified as a result of technology advancements and obsolescence issues.
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VII. PERFORMANCE DATA
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".
Centricity Universal Viewer complies with voluntary standards as detailed in this premarket notification submission.
The following quality assurance measures were applied to the development of the system:
- · Risk Analysis
- Requirements Reviews
- Design Reviews
- Usabilitv Analvsis
- Testing on unit level (Verification)
- · Integration testing (Verification)
- Performance testing (Verification)
- · Regression testing (Verification)
- · System testing (Verification)
- · Simulated use testing (Validation)
The subject of this submission, Centricity Universal Viewer, did not require animal testing, biological testing, sterility testing, electrical safety testing or electromagnetic compatibility testing.
VIII. 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 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 medical device to be as safe, as effective and substantially equivalent to its predicate device.