(36 days)
Not Found
No
The document describes a standard PACS system for image management and display, with no mention of AI or ML capabilities for analysis or interpretation.
No
Explanation: The device is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices. It is a PACS (Picture Archiving and Communications System) software product, which manages and processes medical images but does not directly provide therapy.
Yes
The Centricity PACS software is explicitly stated to be intended "for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals." This indicates its role in aiding the diagnosis of medical conditions based on imaging data.
Yes
The device description explicitly states that "v3.2.1 is a software only product."
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- This device processes medical images: The Centricity PACS software is explicitly described as being for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices. These are images generated by modalities like CT, MRI, X-ray, etc., not analyses of biological samples.
The intended use and device description clearly focus on the management and interpretation of medical images, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
The Centricity PACS Workstation software is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility.
The Centricity PACS provides scalable image and data management solutions for medical imaging modalities, such as Computed Tomography (CT). Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound (US), Nuclear Medicine (NM), Positron Emission Tomography (PET), X-Ray Angiography (XA), Oral X-Ray (IO), Endoscopic Video (ES), and any other DICOM devices.
The workstation interface software provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.
To be viewed for primary interpretation, the digital mammography images must be acquired from an FDA approved Full Field Digital Mammography (FFDM) device for primary interpretation. Furthermore, the FFDM must be able to provide, to the Centricity PACS, a viewable DICOM 'for presentation' mammography image as approved by the FDA for primary interpretation. Images that are printed to film must be printed using a FDA approved printer for the diagnosis of digital mammography images.
To be viewed for primary diagnosis, digital mammography images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images.
The Centricity PACS allows integration with other open interfaces, such as DICOM. to web client products and archive devices.
The Centricity Infrastructure software provides for the system's database and image management, printing, HL-7 interfacing, and all DICOM services including but not limited to, Store, Print, Query/Retrieve, and Send.
It is the user's responsibility to ensure quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, GCJ
Device Description
Centricity PACS is an enterprise grade Picture Archiving and Communications System (PACS) for managing digital medical images and associated data. Centricity PACS enables the storage, retrieval, distribution, printing, and presentation of images acquired from diagnostic imaging modalities.
Centricity PACS is a standards-based, customizable, and scalable solution supporting several of the Integrating the Healthcare Enterprise (IHE) profiles, Digital Imaging and Communications in Medicine (DICOM), and the Health Level Seven (HL7) protocol standards for managing digital medical images and patient data. Centricity PACS supports radiographic imaging-as in clinical radiography, cardiology, dentistry, and mammography and non-radiologic imaging, including video support.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT). Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound (US), Nuclear Medicine (NM), Positron Emission Tomography (PET), X-Ray Angiography (XA), Oral X-Ray (IO), Endoscopic Video (ES), and any other DICOM devices.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses.
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 submission, Centricity PACS, did not require clinical studies to support substantial equivalence.
Summary of Non-Clinical Tests:
Centricity PACS comply with voluntary standards as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Requirements Reviews
- · Design Reviews
- · Testing on unit level (Module verification)
- · Integration testing (System verification)
- · Performance testing (Verification)
- · Safety 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.
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
110875
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | February 11, 2011 |
|---|---|
| Submitter: | GE Healthcare |
| 540 W. Northwest Highway | |
| Barrington, IL 60010 | |
| Primary Contact Person: | Cheryl Bork |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| Phone: 847-277-6038 | |
| Fax: 847-277-5240 | |
| Secondary Contact | |
| Person: | Jeme Wallace |
| Director, Regulatory Affairs | |
| GE Healthcare | |
| Phone: 847-277-4468 | |
| Fax: 847-277-5240 | |
| Device: | |
| Trade | |
| Name: | Centricity PACS |
| Common/Usual | |
| Name: | PACS, Picture Archiving and Communication System |
| Classification Names: | 21 CFR 892.2050 System, Image Processing, Radiological |
| Product Code: | LLZ |
| Secondary Product | |
| Code: | GCJ |
| 876.1500 Endoscope and accessories | |
| Predicate Device(s): | K043415 Centricity™ PACS |
1
| Device Description: | Centricity PACS is an enterprise grade Picture Archiving and
Communications System (PACS) for managing digital medical
images and associated data. Centricity PACS enables the
storage, retrieval, distribution, printing, and presentation of
images acquired from diagnostic imaging modalities.
Centricity PACS is a standards-based, customizable, and
scalable solution supporting several of the Integrating the
Healthcare Enterprise (IHE) profiles, Digital Imaging and
Communications in Medicine (DICOM), and the Health Level
Seven (HL7) protocol standards for managing digital medical
images and patient data. Centricity PACS supports
radiographic imaging-as in clinical radiography, cardiology,
dentistry, and mammography and non-radiologic imaging,
including video support. |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Centricity PACS software product is intended for the storage,
reading, diagnostic review, analysis, annotation, distribution,
printing, editing, and processing of digital images and data
acquired from diagnostic imaging devices.
The Centricity PACS Workstation software is intended for use
as a primary diagnostic and analysis tool for diagnostic
images by trained healthcare professionals, including
radiologists, physicians, technologists, clinicians and nurses. It
is also intended for use as a clinical review workstation
throughout the healthcare facility. |
2
. . . . . . .
| Technology: | Centricity PACS employs the same fundamental scientific |
|---|---|
| technology as its predicate devices. |
| Summary of
Technological
Characteristics: | | Predicate Device
Centricity PACS
K043415 (v2.1) | Proposed Device
Centricity PACS 3.2.1 |
|-------------------------------------------------|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | DESIGN | Centricity PACS is a software
product with optional turnkey
solution for hardware
components.
Centricity PACS is a standards-
based, customizable, and
scalable solution supporting
several of the Integrating the
Healthcare Enterprise (IHE)
profiles, Digital Imaging and
Communications in Medicine
(DICOM), and the Health Level
Seven (HL7) protocol standards
for managing digital medical
images and patient data.
Centricity PACS supports
radiographic imaging-as in
clinical radiography,
cardiology, dentistry, and
mammography and non-
radiologic imaging, including
video support. | Centricity PACS v3.2.1 employs
the same fundamental
scientific technology as its
predicate devices, however
v3.2.1 is a software only
product.
Centricity PACS is a standards-
based, customizable, and
scalable solution supporting
several of the Integrating the
Healthcare Enterprise (IHE)
profiles, Digital Imaging and
Communications in Medicine
(DICOM), and the Health Level
Seven (HL7) protocol standards
for managing digital medical
images and patient data.
Centricity PACS supports
radiographic imaging-as in
clinical radiography,
cardiology, dentistry, and
mammography and non-
radiologic imaging, including
video support. |
| | Material | Not Applicable - Centricity
PACS is a software product,
and therefore, has no specific
materials of manufacture. | Not Applicable - Like the
predicate product, the
Centricity PACS v3.2.1, is a
software only product, and
therefore, has no specific
materials of manufacture. |
| | Chemical
Composition | Not Applicable - Centricity
PACS is a software product,
and therefore, has no specific
chemical composition. | Not Applicable - Like the
predicate product, the
Centricity PACS v3.2.1, is a
software only product, and
therefore, has no specific
chemical composition. |
| | Energy
Source | Not Applicable - Centricity
PACS is a software product,
and therefore, has no Energy
Source. | Not Applicable - Like the
predicate product, the
Centricity PACS v3.2.1, is a
software only product, and
therefore, has no Energy
Source. |
3
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
Centricity PACS comply with voluntary standards as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Requirements Reviews
- · Design Reviews
- · Testing on unit level (Module verification)
- · Integration testing (System verification)
- · Performance testing (Verification)
- · Safety testing (Verification)
- · Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission, Centricity PACS, did not require clinical studies to support substantial equivalence.
GE Healthcare considers Centricity PACS to be as safe, as effective, Conclusion: and performance is substantially equivalent to the predicate device(s).
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
GE Healthcare % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062
MAY - 5 2011
Re: K110875
Trade/Device Name: Centricity PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ and GCJ Dated: March 29, 2011 Received: March 30, 2011
Dear Mr. Devine:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
5
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5.10(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Form
FDA CDRH DMC K56
| 510(k) Number (if known): | |
|---|---|
| Device Name: | Centricity PACS |
| MAR 3 0 2011 | |
|---|---|
| Received |
Indications for Use:
The Centricity PACS provides scalable image and data management solutions for medical imaging modalities, such as Computed Tomography (CT). Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound (US), Nuclear Medicine (NM), Positron Emission Tomography (PET), X-Ray Angiography (XA), Oral X-Ray (IO), Endoscopic Video (ES), and any other DICOM devices.
The workstation interface software provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.
To be viewed for primary interpretation, the digital mammography images must be acquired from an FDA approved Full Field Digital Mammography (FFDM) device for primary interpretation. Furthermore, the FFDM must be able to provide, to the Centricity PACS, a viewable DICOM 'for presentation' mammography image as approved by the FDA for primary interpretation. Images that are printed to film must be printed using a FDA approved printer for the diagnosis of digital mammography images.
To be viewed for primary diagnosis, digital mammography images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images.
The Centricity PACS allows integration with other open interfaces, such as DICOM. to web client products and archive devices.
The Centricity Infrastructure software provides for the system's database and image management, printing, HL-7 interfacing, and all DICOM services including but not limited to, Store, Print, Query/Retrieve, and Send.
It is the user's responsibility to ensure quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 801 Subpart C)
Page 1 of 2
નું
ﻟﻤﻌﺔ
7
Indications for Use Form
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Patel
Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110875