(100 days)
No
The document describes a medical image display and interpretation software with standard image processing capabilities and integrations, but there is no mention of AI or ML technologies being used for analysis or interpretation.
No
The device is described as an "Internet based medical image display and interpretation software product" that assists in viewing, analysis, diagnostic interpretation, and sharing of images. It does not provide therapy or treatment.
Yes
The "Intended Use" section explicitly states that the device is "intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information." Additionally, the "Device Description" mentions that it "assists radiologists and cardiologists in their diagnostic workflows."
Yes
The device description explicitly states it is an "Internet based medical image display and interpretation software product" and that it "does not produce any original medical images." It relies on commercially available computer platforms and operating systems and receives images from external DICOM compliant modalities. While it integrates with third-party devices, the core medical device functionality described is purely software-based for display, processing, and interpretation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Centricity Universal Viewer is a software product that displays, processes, and manages medical images acquired from various imaging modalities (CT, MR, X-ray, etc.). It assists healthcare professionals in the viewing, analysis, and interpretation of these images.
- Lack of Specimen Analysis: The device does not interact with or analyze biological specimens. Its input is medical images, not samples from the human body.
Therefore, while it is a medical device used for diagnostic purposes, it falls under the category of medical imaging software rather than 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
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 ™ [1] 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 mammoaraphy (MG), Digital X-ray (DX), Positron Emission Tomoaraphy (PET/PT), X-Ray Angiography (XA), Digital Intra-oral X-Ray (IO), Radiofluoroscopic X-ray (RF), Secondary Capture Images (SC), Visible Light (VL) Endoscopic 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 Angiography (XA), Digital Intra-oral X-Ray (IO), Radiofluoroscopic X-ray (RF), Secondary Capture Images (SC), Visible Light (VL) Endoscopic 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
Typical users of this system are authorized healthcare professionals.
Designed to be utilized inside and outside of radiology and cardiology.
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
The software documentation was provided for a moderate level of concern device following the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The Centricity Universal Viewer with the proposed modifications has been verified against design requirements and validated against defined user needs and intended uses, in accordance with the voluntary standards as detailed in this premarket notification submission. The same Cath Tools features were previously cleared in the premarket notification K063628.
The performance characteristics of the Centricity Universal Viewer has been verified against design requirements and validated against defined user needs and intended uses as follows:
- Validation of user needs and intended uses was performed using the recommended hardware platform
- System verification testing of system level requirements was performed using the recommended hardware platform
- Regression testing included in verification testing
- Integration and interoperability verification testing of software functional requirements
- Unit testing of Product Design Detail (PDD) statements
- Product usability formative and summative testing
- Cybersecurity analysis
The subject of this submission, Centricity Universal Viewer, did not require animal testing, biological testing, sterility testing, electrical safety testing or electromagnetic compatibility testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and below that, the word "ADMINISTRATION" in blue.
December 14, 2018
GE Healthcare Renee Webb Senior Regulatory Affairs Manager 500 West Monroe Street CHICAGO, IL 60661
Re: K182419
Trade/Device Name: Centricity Universal Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: September 20, 2018 Received: September 26, 2018
Dear Renee Webb:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website
(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Hole 2. Nils
for Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182419
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) |
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3
Image /page/3/Picture/0 description: The image shows the logo for GE Healthcare. On the left is the GE logo, which is a blue circle with the letters "GE" in white. To the right of the logo is the text "GE Healthcare" in black. The text is in a sans-serif font and is aligned to the left.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
SUBMITTER l.
GE Healthcare 500 West Monroe Chicago, IL 60661
Primary Contact Person: Renee Webb Senior Regulatory Affairs Manager GE Healthcare Phone: 847-707-8783
| Secondary Contact Person: | John Manarik |
|---|---|
| Regulatory Affairs Manager | |
| GE Healthcare | |
| Phone: 224-532-0907 |
Date Prepared: December 12, 2018
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 |
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Image /page/4/Picture/0 description: The image shows the logo for GE Healthcare. The logo consists of the GE logo on the left and the words "GE Healthcare" on the right. The GE logo is a blue circle with the letters "GE" in white inside.
III. PREDICATE DEVICE
Primary - K150420 (May 2015)- Centricity Universal Viewer by GE Healthcare Reference - K063628 (December 2006) -Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy.
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 ™ [1] 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 mammoaraphy (MG), Digital X-ray (DX), Positron Emission Tomoaraphy (PET/PT), X-Ray Angiography (XA), Digital Intra-oral X-Ray (IO), Radiofluoroscopic X-ray (RF), Secondary Capture Images (SC), Visible Light (VL) Endoscopic 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.
[1] Tomtec-Arena™ K132544 has been FDA cleared and CE Marked.
5
Image /page/5/Picture/0 description: The image shows the logo for GE Healthcare. The logo consists of the GE monogram enclosed in a circular design with swirling lines, colored in blue. To the right of the monogram is the text "GE Healthcare" in a simple, sans-serif font, with "GE" in a slightly larger font size than "Healthcare".
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. 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.
Mammoaraphy images may only be interpreted using a monitor compliant with requirements of local requlations 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.
The Intended Use / Indications for Use statement is identical to the Predicate device.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject Centricity Universal Viewer device continues to support the display, storage, analysis and processing of various medical images using similar technology.
The basis for this premarket notification is a modification of the legally marketed Centricity Universal Viewer device to incorporate additional features. These modifications do not change the Intended Use. These changes include enhancements and other updates to support customer feedback and to enhance usability of the software application. These modifications improve on the subject device's ability to assist healthcare professionals in the display, storage, processing, and diagnostic analysis of various medical images similarly to the predicate Centricity Universal Viewer.
The Centricity Universal Viewer architecture and SOUP software and software core algorithms have not changed. The Cath Tools algorithm has not changed. Cath Tools adds functionality that already existed in K063628 onto the Centricity Universal Viewer software technology stack.
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Image /page/6/Picture/1 description: The image shows the logo for GE Healthcare. The logo consists of a blue circular emblem with a stylized "GE" inside, followed by the text "GE Healthcare" in black. The text is positioned to the right of the emblem and is written in a clear, sans-serif font.
The following table contains a comparison of the key changes since the last 510k clearance K150420:
| Feature | Predicate Device
Centricity Universal
Viewer
(K150420) | Subject Device
Centricity Universal
Viewer
with Cath Tools | Discussion of
Differences |
|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Identical to
predicate device | No change |
| Contraindication | Centricity Universal Viewer
is contraindicated for the
use of lossy compressed
mammographic images. | Identical to
predicate device | No change |
| Feature | Predicate Device
Centricity Universal
Viewer
(K150420) | Subject Device
Centricity Universal
Viewer
with Cath Tools | Discussion of
Differences |
| | Lossy compressed
mammographic images
and digitized film screen
images must not be
reviewed for primary image
interpretations. | | |
| Cath Analysis
Tools | Not supported | Supported in the
subject device.
The following tools
are available to help
perform an analysis
of images received
as a result of a
catheterization
procedure:
- Stenosis Analysis
- Left ventricular
analysis - Catheter
calibration
• Point to Point
Calibration
• Calibration
extension - Distance
measurement | Equivalent. Cath
Tools modifications
do not change the
Intended Use. The
Cath Tools
functionality added is
identical to the Cath
Tools in GE
Healthcare's,
Centricity Radiology
RA600, Cardiology
CA1000 cleared
under K063628. Test
results for these
modifications do not
raise different issues
of safety or
effectiveness. There
are no new potential
hazards and no
changes to existing
potential hazards,
and no change in the
final risk ratings for
the device. |
| Workflow | | | |
| Interactive
search for
studies | Search by: - Patient name
- ID
- Accession Number
- Study date
- Study description
- Modality
- Study status
- Referring Physician
- Date of Birth
- Referring Service | Same as predicate,
except:
- Retrieval of off-
line study - Access to
confidential
patient studies
based on
privileges - Increase number
of studies the | Equivalent. Adding
the modifications
under interactive
search for studies
does not impact the
device safety and
effectiveness. |
| Feature | Predicate Device
Centricity Universal
Viewer
(K150420) | Subject Device
Centricity Universal
Viewer
with Cath Tools | Discussion of
Differences |
| | 11. Priority
- Online status (CPACS
only) - 0 image studies
(CPACS only) - Performing physician
- Location (Enterprise
Archive (EA) only for
Cardiology) | worklist can
display and
remove 30 study
limit on custom
worklists
- Support for
Technologist
study verification
workflow and
teaching folder - Create, access,
save and display
key images | |
| Search from
DICOM server | Search for studies
located on the external
DICOM compliant server.
Supported only on IW
backend | Same as predicate,
except: - search and
retrieve prior
exams from
external DICOM
server - save and display
DICOM grayscale
presentation
state object to
work with any
type of under-
lying hanging
protocol | Equivalent. Adding
the modifications
under the search
from DICOM server
does not impact the
device safety and
effectiveness. |
| Image Display | | | |
| Ability to display
information | Ability to display the
following:
- Image
- Report
- Patient information
- Exam information
- DICOM Header
information - GSPS
- RPPS
- FCE
- Key Image Notes
- Exam Notes | Same as predicate,
except:
- native support of
diagnostic
interpretation for
2D and DBT
mammo images - user, group and
system level step
protocols - support DICOM
metadata in
overlay / | Equivalent. These
modifications do not
change the Intended
Use. The device
continues to support
the display, storage,
analysis and
processing of various
medical images using
a similar technology.
Test results for these
modifications do not
raise different issues |
| Feature | Predicate Device
Centricity Universal
Viewer
(K150420) | Subject Device
Centricity Universal
Viewer
with Cath Tools | Discussion of
Differences |
| | 11. Modality and VOI LUT
- Structured Reports | annotation editor
- support
synchronized ECG
curve, ECG scroll
and ECG curve
height selector - support Dorsal
view (Reverse
ACR IHE) for
mammography | of safety or
effectiveness. There
are no new potential
hazards and no
changes to existing
potential hazards,
and no change in the
final risk ratings for
the device. |
| Image
Annotations and
measurements | 1. Line
- Angle
- SUV
- OB Measurements
- Digital Subtraction
Angiography (DSA) - Triangulation
- MIP/MPR
- Spine Labeling
- Using "imager pixel
spacing" - DICOM field to
enable measurements
across all CR/DX/US
exams. - Cardio Thoracic Ratio
(CTR) - Image Annotations | Same as predicate,
except:
- Automatically
mark images as
key when image is
annotated - Use "imager pixel
spacing" DICOM
field to enable
measurements
across CR/DX/US
exams | Equivalent. Adding
the modifications for
image annotations
and measurements
does not impact the
device safety and
effectiveness. These
enhancements
provide information
already available to
be used in the same
way as the predicate,
for the same purpose
and by the same
users. |
| Customized
Hanging
Protocols | Smart Reading Protocols
-Regular Hanging
protocols to launch
multiple MIP/MPRs | Same as predicate,
except: - multi-modality and
multi-vendor
hanging protocol - dedicated toolbar
for mammography
features - smart reading
protocols learn
user's preferences
for MRI
multiphasic
studies | Equivalent. Adding
the modifications for
customized hanging
protocols does not
impact the device
safety and
effectiveness. These
enhancements
provide information
to be used in the
same way as the
predicate, for the
same purpose and by
the same users. |
| Maximum
Intensity | Maximum Intensity
Projection (MIP) MIP with | Same as predicate,
except: | Equivalent. These
modifications do not |
| Feature | Predicate Device
Centricity Universal
Viewer
(K150420) | Subject Device
Centricity Universal
Viewer
with Cath Tools | Discussion of
Differences |
| Projection (MIP)
MIP with
interactive
window-level
clipping volume
of interest,
zoom, pan, and
rotate | interactive window-level
clipping volume of
interest, zoom, pan, and
rotate | - Recalculate
standard update
value on the fly for
PET/CT images - Multi-planar
reconstruction
support multiple
oblique
reconstruction - Support for non-
square pixel image
calibration | change the Intended
Use. The device
continues to support
the display, storage,
analysis and
processing of various
medical images using
a similar technology.
Test results for these
modifications do not
raise different issues
of safety or
effectiveness. There
are no new potential
hazards and no
changes to existing
potential hazards,
and no change in the
final risk ratings for
the device. |
| Printing | | | |
| Key
Images/Print
Pages | Created Print Pages from
selected Key Images,
one-click placement;
customized templates;
one click-full screen
snapshot | Identical to
predicate device | No change |
| Print to Film /
Paper | Print collage of images to
printer | Identical to
predicate device | No change |
| Connectivity,
Interfaces &
Interoperability | | | |
| Integration | Integration COM service | Identical to
predicate device | No change |
| Interfaces | Generic interface to
integrate outbound with
third party applications
and internal GEHC
applications that meet
the interface
requirements. | Same as predicate,
except: - Update to API
connectivity to
launch newer
versions of 3rd
party software | Equivalent. Adding
modifications for the
interfaces does not
impact the device
safety and
effectiveness. There
are no new potential
hazards. |
| Feature | Predicate Device
Centricity Universal
Viewer
(K150420) | Subject Device
Centricity Universal
Viewer
with Cath Tools | Discussion of
Differences |
| | | applications such
as GE Healthcare's
EchoPAC and
Advantage
Workstation
applications | hazards and no
changes to existing
potential hazards,
and no change in the
final risk ratings for
the device. |
| External system
launch | The viewer can be
launched via a 3rd party
application using the
following methods:
- url launch
- IVAPI
- Inbound API | Same as predicate,
except:
- Updates in
interfaces with 3rd
party software
applications - URL launch using
SUID when study
associated with
multiple orders | Equivalent. Adding
modifications under
external system
launch does not
impact the device
safety and
effectiveness. These
enhancements
provide information
to be used in the
same way as the
predicate, for the
same purpose and by
the same users. |
| Administrative | | | |
| Interactive
query | In console, supporting
wildcards | Identical to
predicate device | No change |
| Setup | Wizard and silent | Identical to
predicate device | No change |
| On-line help | Yes | Identical to
predicate device | No change |
| User Interface
and User
Manual
Languages | 1. English, 2. German,
- Japanese, 4. French,
- Simplified Chinese
- Italian, 7. Polish, 8.
Spanish - Turkish, 10. Brazilian
Portuguese, 11. Dutch, - Swedish, 13. Russian
- Korean, 15. Finnish,
- Danish, 17.
Norwegian, - Traditional Chinese
- Portuguese, 20.
Greek, - Hungarian | Identical to
predicate device | No change |
| Feature | Predicate Device Centricity Universal Viewer (K150420) | Subject Device Centricity Universal Viewer with Cath Tools | Discussion of Differences |
| Administrative rights assignment | Per user/group | Identical to predicate device | No change |
| Automatic notification messages | By email. HL7 | Same as predicate, except: - auto refresh and notification when new images arrive - merge two studies into one - audit log to track export of images | Equivalent. Adding modifications under automatic notification messages does not impact the device safety and effectiveness. These enhancements provide information to be used in the same way as the predicate, for the same purpose and by the same users. |
| System logging | Combined system log | Identical to predicate device | No change |
| Compression | Wavelet compression - JPEG2000 lossless
- JPEG2000 lossy
Non-wavelet compression - JPEG lossless
- JPEG lossy
JPEG2000 lossless for images received uncompressed | Identical to predicate device | No change |
| Minimal System Requirements
Offering | 1. Turnkey solution (GEHC IT provides both the software and hardware required to function as a complete system) - Software only solution (GEHC IT provides and deploys the Software). | Identical to predicate device | No change |
| ESXi | VMware vSphere ESXi | Identical to predicate device | No change |
| Feature | Predicate Device
Centricity Universal
Viewer
(K150420) | Subject Device
Centricity Universal
Viewer
with Cath Tools | Discussion of
Differences |
| Workstation
Features | | | |
| Operating
System for
Diagnostic
Workstation | Microsoft™ Windows 7 -
64 bit
Microsoft™ Windows 8.1
- 64 bit | Same as predicate,
except: - adding support for
Windows 10
operating system
32 or 64 bit with
Internet Explorer
11 | Equivalent. Adding
support for Windows
10 operating system
32 or 64 bit with
Internet Explorer 11
does not impact the
device safety and
effectiveness. |
| Minimum
Hardware
requirement for
Diagnostic
Workstation | 2 Quad-core processor of
2.0
GHz or more
8GB RAM minimum
146GB drive in Raid 0
configuration
DVD-RW Optical drive
One 1GB NIC
10/100/1000 Mb
Ethernet
network
4 Mbps and faster TCP-IP
network | Identical to
predicate device | No change |
| Security | | | |
| User
Authentication
using a 3rd
Party
Authentication
Server | Active Directory | Same as predicate,
except: - Provides common
authentication - security
hardening and
cybersecurity
improvements | Equivalent. Adding
common
authentication
support and security
hardening does not
impact the device
safety and
effectiveness. |
| Enterprise
Imaging | | | |
| DICOM Protocol | 1. Supports DICOM SOP
classes
- Receive images -
DICOM storage SCP - Support DICOM 3.0
input | Same as predicate,
except:
- support additional
color (YBR)
interpretations
with US images - support saving | Equivalent. Adding
modifications under
DICOM protocol does
not impact the device
safety and
effectiveness. These
enhancements |
| Feature | Predicate Device
Centricity Universal
Viewer
(K150420) | Subject Device
Centricity Universal
Viewer
with Cath Tools | Discussion of
Differences |
| | presentation states | image calibration
information in
Presentation
State | provide information
to be used in the
same way as the
predicate, for the
same purpose and by
the same users. |
| (XED) Cross
Enterprise
Display | Provides the ability to
view patient information
across multiple
enterprise sites based on
matching patient ID
numbers. | Same as predicate,
except: - New API to access
patient history in
FHIR format and
from different
sources - Enhance ability to
group studies
anatomically - matching patient
studies from
remote sites with
the same patient | Equivalent. Adding
modifications under
cross enterprise
display does not
impact the device
safety and
effectiveness. These
enhancements allow
patient history to be
used in the same way
as the predicate, for
the same purpose
and by the same
users. |
| User
Environment | Designed to be utilized
inside and outside of
radiology and cardiology | Identical to
predicate device | No change |
| Designed to be
utilized inside
and outside of
radiology | | | |
7
Image /page/7/Picture/0 description: The image shows the GE Healthcare logo. The logo consists of a blue circular emblem with a stylized "GE" inside. To the right of the emblem, the words "GE Healthcare" are written in a bold, sans-serif font. The text is black, providing a strong contrast against the white background.
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Image /page/8/Picture/0 description: The image contains the logo for GE Healthcare. The logo consists of a circular emblem on the left and the text "GE Healthcare" on the right. The emblem is blue and features a stylized "GE" monogram. The text "GE Healthcare" is in a bold, sans-serif font.
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Image /page/9/Picture/0 description: The image shows the GE Healthcare logo. The logo consists of a blue circular emblem with a stylized "GE" inside, followed by the text "GE Healthcare" in a bold, sans-serif font. The text is black and positioned to the right of the emblem.
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Image /page/10/Picture/0 description: The image shows the GE Healthcare logo. The logo consists of a blue circular emblem with a stylized "GE" inside. To the right of the emblem, the words "GE Healthcare" are written in a bold, sans-serif font. The text is black, providing a strong contrast against the white background.
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Image /page/11/Picture/0 description: The image shows the GE Healthcare logo. The logo consists of a blue circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the words "GE Healthcare" are written in a bold, sans-serif font. The text is black, providing a strong contrast against the white background.
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Image /page/12/Picture/0 description: The image shows the logo for GE Healthcare. The logo consists of a blue circular emblem with a stylized "GE" monogram inside. To the right of the emblem is the text "GE Healthcare" in a bold, sans-serif font. The text is black and stands out against the white background.
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Image /page/13/Picture/0 description: The image contains the GE Healthcare logo. The logo consists of a circular emblem with the letters 'GE' intertwined in a stylized font. To the right of the emblem, the words 'GE Healthcare' are written in a clear, sans-serif font. The emblem is in blue, while the text is in black.
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Image /page/14/Picture/0 description: The image shows the GE Healthcare logo. The logo consists of a blue circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the words "GE Healthcare" are written in a simple, bold, sans-serif font. The text is black, contrasting with the white background.
VII. PERFORMANCE DATA
Summary of Non-Clinical Tests
The software documentation was provided for a moderate level of concern device following the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The Centricity Universal Viewer with the proposed modifications has been verified against design requirements and validated against defined user needs and intended uses, in accordance with the voluntary standards as detailed in this premarket notification submission. The same Cath Tools features were previously cleared in the premarket notification K063628.
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Image /page/15/Picture/1 description: The image shows the logo for GE Healthcare. The logo consists of the letters 'GE' in a stylized blue circle on the left. To the right of the logo is the text 'GE Healthcare' in black font. The text is aligned horizontally with the logo.
The performance characteristics of the Centricity Universal Viewer has been verified against design requirements and validated against defined user needs and intended uses as follows:
- Validation of user needs and intended uses was performed using the recommended hardware platform
- System verification testing of system level requirements was performed using the recommended hardware platform
- · Regression testing included in verification testing
- Integration and interoperability verification testing of software functional requirements
- · Unit testing of Product Design Detail (PDD) statements
- · Product usability formative and summative testing
- · Cybersecurity analysis
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
A comparison of the Intended Use / 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 demonstrate that the Centricity Universal Viewer continues to provide a reasonable assurance of safety and effectiveness with respect to the intended use of each feature. Regression testing confirmed that changes did not affect previously cleared features of the Centricity Universal Viewer.
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.