(15 days)
Not Found
No
The document does not mention AI, ML, or related terms like deep learning or neural networks. The description focuses on standard PACS functionalities like image transmission, storage, display, and basic processing.
No
The device is described as an image display software application for reading, diagnostic review, and analysis of digital images, not as a device that provides therapeutic treatment.
Yes
The device is described as being used by physicians and other personnel for "reading, diagnostic review, and analysis of digital images" from various imaging devices, directly supporting diagnostic activities.
Yes
The device is described as an "image display software application" and its function is to transmit, store, and display images. While it interacts with imaging devices, the description focuses solely on the software's role in handling and presenting the images. The predicate devices are also described as workstations, implying a software-centric function for image review.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is used to "transmit, store and display images" and for "reading, diagnostic review, and analysis of digital images acquired from imaging devices". This describes a system that processes and presents medical images, not a system that performs tests on biological samples (which is the core function of an IVD).
- Device Description: While the description mentions image processing, it's within the context of displaying and reviewing medical images, not analyzing biological samples.
- Input: The input is digital images from various medical imaging modalities (CT, MR, etc.), not biological samples like blood, urine, or tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
The device is a medical image management and display system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Centricity PACS Plus system is used to transmit, store and display images throughout a clinical environment. The Centricity PACS Plus is an image display software application that is intended for use by qualified physicians and other personnel for reading, diagnostic review, and analysis of digital images acquired from imaging devices such as CT, MR, CR, DX, MG, US, NM, PET, and other devices. As a part of the PACS Plus system the Centricity RA1000 is used to view digital images that are obtained from a GE Centricity PACS System, or another DICOM device.
Product codes
90 LLZ
Device Description
See Attachment #2
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, CR, DX, MG, US, NM, PET, and other devices.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians and other personnel
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
Not Found
Key Metrics
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).
0
7 2002 NOV
GE Medical Systems Information Technologies
1023557 Centricity PACS Plus 510 (k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87 (h)
-
- Identification of submitter: Scott R. Evans Regulatory Affairs Specialist Telephone: 847-704-8878 Fax: 847-704-8560
Date Prepared: September 26th, 2002
- Identification of submitter: Scott R. Evans Regulatory Affairs Specialist Telephone: 847-704-8878 Fax: 847-704-8560
2. Identification of Product:
| Device name | Centricity PACS Plus |
|---|---|
| Classification name | PACS per 21CFR Section 892.2050 |
| Manufacturer/ | General Electric Medical Systems |
| Distributor | 800E. Business Center Drive |
| Mount Prospect, IL 60056 | |
| USA |
3. Marketed Devices
Centricity PACS Plus is substantially equivalent to the devices listed below:
| Model: | Platinum Reading and Review Workstation |
|---|---|
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K981217 |
| Model: | Siemens SieNET |
|---|---|
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K920319 |
4. Device Description :
See Attachment #2
1
5. Indications for Use
The Centricity PACS Plus system is used to transmit, store and display images throughout a clinical environment. The Centricity PACS Plus is an image display software application that is intended for use by qualified physicians and other personnel for reading, diagnostic review, and analysis of digital images acquired from imaging devices such as CT, MR, CR, DX, MG, US, NM, PET, and other devices. As a part of the PACS Plus system the Centricity RA1000 is used to view digital images that are obtained from a GE Centricity PACS System, or another DICOM device.
6. Comparison with Predicate Device
Centricity PACS Plus is substantially equivalent to the devices listed below:
| Model: | Platinum Reading and Review Workstation | |
|---|---|---|
| Manufacturer: | General Electric Medical Systems | |
| 510 (k): | K981217 | |
| Model: | Siemens SieNET | |
| Manufacturer: | General Electric Medical Systems | |
| 510 (k): | K920319 |
These workstations allow easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.
7. Conclusions
Centricity PACS Plus brings additional features in order to integrate seamlessly into the Radiology Department Workflow.
The entire potential new hazards has been studied by a Risk Management Plan:
- . Risk Management Summary
- A software development and validation process
- A software verification plan .
Centricity PACS Plus provides images comparable to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized depiction of an eagle's head and neck, composed of three parallel, curved lines. The eagle faces to the right. The words "DEPARTMENT OF TRANSPORTATION" are arranged in a circular fashion around the eagle, with the text oriented to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
General Electric Medical Systems % Mr. Heinz Joerg Steneberg Division Manager Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
· Re: K023557
Trade/Device Name: Centricity PACS Plus Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II Product Code: 90 LLZ
Dated: October 21, 2002 Received: October 23, 2002
Dear Mr. Steneberg:
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 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 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.
3
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INTENDED USE
K023557 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device name: Centricity PACS Plus
Indication For Use:
The Centricity PACS Plus system is used to transmit, store and display images throughout a clinical environment. The Centricity PACS Plus is an image display software application that is intended for reading, diagnostic review, and analysis of digital images acquired from imaging devices such as CT, MR, CR, DX, MG, US, NM, PET, and other devices. As a part of the PACS Plus system the Centricity RA1000 is used to view digital images that are obtained from a GE Centricity PACS System, or another DICOM device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | ------------- |
-OR-
| Over-The-Counter Use | |
|---|---|
| ---------------------- | ------------- |
Nancy Corogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K023557 |
|---|---|
| --------------- | --------- |