(28 days)
No
The document describes a standard PACS system for image storage, communication, processing, and display. There is no mention of AI, ML, or related terms, nor are there descriptions of training or test sets typically associated with AI/ML development.
No
This device is a Picture Archiving and Communication System (PACS) that receives, stores, processes, and displays medical images. It does not provide any direct diagnostic or therapeutic function to a patient.
No
The device is a Picture Archiving and Communication System (PACS) that receives, stores, communicates, processes, and displays medical images. Its primary function is image management and review, not to provide a diagnosis itself. It states "Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations." and "The system does not produce any original medical images." indicating it's for display and management of diagnostic images produced by other devices, rather than performing diagnosis.
Yes
The device description explicitly states that Centricity PACS-IW is an "internet based software picture archiving and communications system" and is designed to be deployed over "commercially available computer hardware platforms and operating systems," indicating it is software running on general-purpose hardware. It also states the system "does not produce any original medical images," further supporting its software-only nature as it processes images generated by other devices.
Based on the provided text, Centricity PACS-IW is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Centricity PACS-IW Function: The description clearly states that Centricity PACS-IW receives, stores, processes, and displays medical images from various imaging modalities (CT, MR, X-ray, etc.). It does not analyze biological specimens.
The device is a Picture Archiving and Communication System (PACS), which is a type of medical imaging software.
N/A
Intended Use / Indications for Use
Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-approved monitor that offers at least five Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Product codes
LLZ
Device Description
Centricity PACS-IW is an internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms).
Centricity PACS-IW includes features to access and manage medical imaging studies and data from computed tomography (CT), magnetic resonance (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital mammoqraphy (MG), digital x-ray (DX), special procedures and Interventional radiography (XA), PET/CT scan (PT), and other imaging modalities.
Centricity PACS-IW is designed to be deploved over conventional TCP/IP networking infrastructure available in most healthcare organizations utilizing commercially available computer hardware platforms and operating systems. The system does not produce any original medical images. All images located in the Centricity PACS-IW have been received from DICOM compliant modalities and/or 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 radiography (DR), digital mammoqraphy (MG), digital x-ray (DX), special procedures and Interventional radiography (XA), PET/CT scan (PT)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this system are trained professionals, including but 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 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 PACS-IW 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.
- . Usability Analysis
- . 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 premarket notification submission, Centricity PACS-IW, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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JUN - 5 2012
UN - 4 2019
GE Healthcare 510(k) Premarket Notification Submission Section 5: 510(k) Summary
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
May 04, 2012 Date:
Submitter: GE Healthcare 540 West Northwest Highway Barrington, IL 60010
Primary Contact Person: John Manarik Regulatory Affairs Manager GE Healthcare Phone: 847-277-5504 Fax: 847-277-5240
Jeme Wallace Secondary Contact Requlatory Affairs Director Person: GE Healthcare Phone: 847-277-4468 Fax: 847-939-1446
Device Trade Name: Centricity* PACS-IW
Common/Usual Name: Picture Archiving and Communication System
Classification Names: 21 CFR 892.2050, System, Image Processing, Radiological
Product Code: LLZ
Predicate Device: K082318 - GE Healthcare Centricity PACS-IW
" GE, the GE Monogram and Centricity are trademarks of General Electric Company
Page 5 - 2
Image /page/0/Picture/17 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized and connected, and there are decorative swirls around the letters.
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are black, creating a strong contrast against the white background.
GE Healthcare 510(k) Premarket Notification Submission Section 5: 510(k) Summary
Device Description: Centricity PACS-IW is an internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms).
Centricity PACS-IW includes features to access and manage medical imaging studies and data from computed tomography (CT), magnetic resonance (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital mammoqraphy (MG), digital x-ray (DX), special procedures and Interventional radiography (XA), PET/CT scan (PT), and other imaging modalities.
Centricity PACS-IW is designed to be deploved over conventional TCP/IP networking infrastructure available in most healthcare organizations utilizing commercially available computer hardware platforms and operating systems. The system does not produce any original medical images. All images located in the Centricity PACS-IW have been received from DICOM compliant modalities and/or systems.
Intended Use: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammoarams) and data from various imaging sources. Images and data can be stored, communicated, processed and displaved within the system or across computer networks at distributed locations.
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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 logo is black and white.
GE Healthcare 510(k) Premarket Notification Submission Section 5: 510(k) Summary
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-approved monitor that offers at least five Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
Technology: The Centricity PACS-IW device employs the same fundamental scientific technology as its predicate device, Centricity PACS-IW cleared under K082318, with the following modifications:
. Uparade of the Windows server and database management systems; and
. Support for JPEG lossless and JPEG non-wavelet compression techniques
Centricity PACS-IW receives medical images and other information from various data sources. The information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations, the same as its predicate devices. Centricity PACS-IW is a softwareonly device that runs on commercially available off-theshelf computer hardware platforms.
The Centricity PACS-IW 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.
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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, with the letters and border appearing in black against a white background.
GE Healthcare 510(k) Premarket Notification Submission 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". Centricity PACS-IW 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 .
- . Usability Analysis
- . Testing on unit level (Verification)
- . Integration testing (Verification)
- . Performance testing (Verification)
- . Regression testing (Verification)
- System testing (Verification) .
- . Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket notification submission, Centricity PACS-IW, did not require clinical studies to support substantial equivalence.
Conclusion: Comparison of the Intended Uses, 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.
Information provided in this premarket notification submission supports the Centricity PACS-IW medical device to be as safe, as effective and substantially equivalent to its predicate device.
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The text is in all caps and is smaller than the eagle symbol.
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
JUN - 5 2012
Mr. John Manarik Regulatory Affairs MAnager GE Healthcare, HCIT 540 W. Northwest Highway BARRINGTON IL 60010
Re: K121387
Trade/Device Name: Centricity* PACS-IW Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 4, 2012 Received: May 8, 2012
Dear Mr. Manarik:
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 (reporting of
5
medical device-related adverse events) (21 CFR 803); and good manufacturing practice mediour active related as rebe quality systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quarny of evice as described in your Section 510(k) premarket whitication. 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 11 you destre poverily ad receive 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 I valual 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,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K121387
Device Name:
Centricity" PACS-IW
Indications for Use:
Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-approved monitor that offers at least five Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __No (Part 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 Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510k)
Page 1 of
- GE, the GE Monogram and Centricity are trademarks of General Electric Company