(36 days)
Not Found
No
The document describes a standard PACS system for image storage, transfer, display, and processing, with no mention of AI or ML capabilities.
No
The device is a Picture Archiving and Communication System (PACS) that receives, stores, processes, and displays medical images. It does not directly treat or diagnose conditions, which are characteristics of a therapeutic device.
No
This device is a Picture Archiving and Communication System (PACS) that displays and stores medical images. It does not produce original medical images nor does it directly diagnose medical conditions. It serves as a tool for medical professionals, who then use the images to make diagnoses.
Yes
The device is described as an "Internet based software picture archiving and communications system" that utilizes "commercially available computer platforms" and "operating systems." It explicitly states it "does not produce any original medical images" and receives images from DICOM compliant modalities. The description focuses solely on the software's functions of receiving, transferring, displaying, storing, and processing images, without mentioning any proprietary hardware components included as part of the device itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Centricity PACS Web DX system "receives medical images... from various imaging sources." It then stores, communicates, processes, and displays these images. It explicitly states, "The system does not produce any original medical images."
- Lack of Biological Sample Analysis: The device's function is centered around handling and displaying medical images, not analyzing biological samples.
Therefore, the Centricity PACS Web DX system falls under the category of medical imaging software and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Centricity PACS Web Diagnostic (Web DX) PACS System by GE Healthcare Dynamic Imaging Solutions 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 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Product codes
LLZ
Device Description
Centricity PACS Web Diagnostic (Web DX) PACS System is an Internet bases 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 Web Diagnostic (Web DX) PACS System includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital mammography (DM), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. Centricity PACS IW ™ PACS System is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms (Intel Pentiumbased) and operating systems (Microsoft Windows 2000, Windows 98). The system does not produce any original medical images. All images located on Centricity PACS Web Diagnostic (Web DX) PACS System have been received from DICOM compliant modalities and/or systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital mammography (DM), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072986 IntegradWeb™ PACS System by GE Healthcare Dynamic Imaging Solutions, K043415 Centricity PACS System by GE Medical Systems
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).
0
GE Healthcare Integrated IT Solutions
Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a circular border. There are decorative flourishes around the letters, adding to the logo's distinctive appearance. The logo is black and white.
510(k) Summary Section 5:
NOV 1 4 2008 GE Healthcare Dynamic Imaging Solutions Submitter: 40 Boroline Road Allendale, NJ 07401 Contact Person: Jillian M. Reed Consultant Reed Technical Associates, LLC Date Prepared: October 7, 2008 Picture Archiving Communications System Classification Name: Proprietary Name: Centricity PACS Web Diagnostic (Web DX) PACS System Predicate Devices: #K072986 IntegradWeb™ PACS System by GE Healthcare Dynamic Imaging Solutions #K043415 Centricity PACS System by GE Medical Systems
Device Description:
Centricity PACS Web Diagnostic (Web DX) PACS System is an Internet bases 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 Web Diagnostic (Web DX) PACS System includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital mammography (DM), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. Centricity PACS IW ™ PACS System is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms (Intel Pentiumbased) and operating systems (Microsoft Windows 2000, Windows 98). The system does not produce any original medical images. All images located on Centricity PACS Web Diagnostic (Web DX) PACS System have been received from DICOM compliant modalities and/or systems.
Intended Use:
Centricity PACS Web Diagnostic (Web DX) PACS System by GE Healthcare Dynamic Imaging Solutions 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 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, which has decorative elements resembling small, stylized leaves or flourishes around the perimeter.
GE Healthcare Integrated IT Solutions
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
Technical Characteristics:
This device is a medical device image software that is used with computer hardware in a picture archiving and communications system user environment. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.
Substantial Equivalence:
Testing performed has shown that the Centricity PACS Web DX) PACS System incorporating the new connector and streaming service allowing for images stored in the Centricity PACS System (CPACS) to be viewed on the web-based viewer of the Centricity PACS IW™ is substantially equivalent to the above referenced predicate devices.
Discussion of Non-Clinical Testing Performed:
Thorough system verification and validation testing was performed to ensure the safe and effective use of the Centricity PACS Web Diagnostic (Web DX) PACS System.
Conclusions:
The information provided in this special premarket notification submission has shown that the Centricity PACS Web Diagnostic (Web DX) PACS System is substantially equivalent to the predicate device and is safe and effective for its intended use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2008
GE Healthcare Dynamic Imaging Solutions % Ms. Jillian M. Reed Consultant Reed Technical Associates, LLC 25 Walnut Street MONROE CT 06468
- Re: K083018
Trade/Device Name: Centricity PACS Web Diagnostic (Web DX) PACS System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 7, 2008 Received: October 16, 2008
Dear Ms. Reed:
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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
hope M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known)
Indications for Use
510(k) Number (if known): K083018
Device Name: Centricity PACS Web Diagnostic (Web DX) PACS System
Indications for Use:
Centricity PACS Web DX) PACS System by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicallyd, processed and displayed within the system or across computer networks at distributed locations.
Lossy compressed matther mages and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using and TDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed argepted by FDA.
Typical users of this system are trained professionals, including but not the physicians, radiologists, nurses, medical technicians, and assistants.
Prescription Use XXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helen Reeves
(Division Sign-Off) Division of Reproductive, Abdominal an Radiological Devices 510(k) Number __
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