(12 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 any description of training or test sets typically associated with AI/ML development. The "image processing" mentioned is likely standard PACS functionalities like windowing, leveling, etc., not AI-driven analysis.
No
The device is a Picture Archiving and Communication System (PACS) that receives, stores, processes, and displays medical images. It does not provide any therapeutic intervention.
No
The device is a Picture Archiving and Communication System (PACS) that stores, communicates, processes, and displays medical images. It does not produce original medical images nor does it directly aid in diagnosis, but rather manages diagnostic images.
Yes
The device description explicitly states it is an "Internet bases software picture archiving and communications system" and utilizes "commercially available computer platforms" and "operating systems," indicating it is software running on general-purpose hardware, not a dedicated hardware device.
Based on the provided information, 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 to detect diseases or other conditions.
- Device Function: The description clearly states that Centricity PACS IW™ is a system for receiving, storing, communicating, processing, and displaying medical images from various imaging modalities (CT, MR, X-ray, etc.). It does not perform any tests on biological samples.
- Input: The input is medical images, not biological specimens.
- Output: The output is processed and displayed medical images and data, not diagnostic results derived from analyzing biological samples.
Therefore, Centricity PACS IW™ falls under the category of medical imaging software and systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Centricity PACS IW ™ 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 IW ™ 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 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 Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Microsoft Windows 98). The system does not produce any original medical images. All images located on Centricity PACS IW ™ 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)
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)
A reader evaluation, consisting of 11 board certified Radiologist was conducted where they evaluated the new enhanced PET-CT user preferences to the predicate device on actual clinical cases.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K0823/8
GE Healthcare Intearated IT Solutions
Image /page/0/Picture/2 description: The image shows a black and white drawing of a circular shape. The drawing is made up of many small dots, which create a textured effect. The dots are arranged in a way that suggests a swirling or spiraling pattern within the circle. The overall impression is that of a stylized or abstract representation of a circular form.
510(k) Summary Section 5:
AUG 2 5 2008
- GE Healthcare Dynamic Imaging Solutions Submitter: 40 Boroline Road Allendale, NJ 07401 Jillian M. Reed Contact Person: Consultant Reed Technical Associates, LLC Date Prepared: August 12, 2008 Classification Name: Picture Archiving Communications System Proprietary Name: Centricity PACS IW ™ PACS System #K031311 IntegradWeb™ PACS System by Dynamic Imaging, Inc. Predicate Devices: #K042313 IntegradWeb™ MRP/MIP™ by Dynamic Imaging, Inc. #K072986 IntegradWeb™ PACS System by GE Healthcare Dynamic Imaging Solutions #K051673 Xeleris 2 Processing and Review Workstation by GE Medical Systems
Device Description:
Centricity PACS IW ™ 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 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 Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Windows 98). The system does not produce any original medical images. All images located on Centricity PACS IW ™ PACS System have been received from DICOM compliant modalities and/or systems.
Intended Use:
Centricity FACS IW ™ PACS System by Dynamic Imaging, Inc. 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.
CONFIDENTIAL
1
Image /page/1/Picture/0 description: The image shows a black and white abstract pattern. The pattern appears to be a circular design with swirling lines and dots. The overall impression is one of complexity and movement. The image is somewhat grainy and lacks sharp details.
12
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 IW ™ PACS System incorporating enhanced PET-CT user preferences 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 IW ™ PACS System with enhanced PET-CT user preferences.
Discussion of Clinical Testing Performed:
A reader evaluation, consisting of 11 board certified Radiologist was conducted where they evaluated the new enhanced PET-CT user preferences to the predicate device on actual clinical cases.
Conclusions:
The information provided in this special premarket notification submission has shown that the Centricity PACS IN ™ PACS System with enhanced PET-CT user preferences is substantially equivalent to the predicate device and is safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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 wing and tail feathers, positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2008
GE HealthCare Dynamic Imaging System % Ms. Jillian M. Reed Consultant Reed Technical Associates, LLC 25 Walnut Street MONROE CT 06468
Rc: K082318
Trade/Device Name: Centricity PACS IWTM PACS System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 12, 2008 Received: August 13, 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
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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.
Nancy Brogdon
Nancy C. Brogdon 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): K082318
Device Name: Centricity PACS IW ™ PACS System
Indications for Use:
Centricity PACS IW ™ 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.
Typical users of this system are trained professionals, including but not limited to 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)
fonguithon
(Division S Division of Reproductive, Abdominal a Radiological Devices 510(k) Number
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