(73 days)
No
The summary describes a server and client software system for accessing, processing, and viewing DICOM images. It focuses on networking, image selection, processing, and filming. There is no mention of AI, ML, deep learning, or any related terms or concepts that would indicate the use of such technologies for image analysis or interpretation. The description of image processing appears to refer to standard image manipulation and compression techniques.
No
The device processes and displays medical images for diagnosis but does not directly treat or prevent a disease or condition, which is characteristic of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section states: "For other images, trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application." Additionally, the "Device Description" section clarifies: "AW Server is intended to be used to create and review diagnostic evidence related to radiology procedures by trained physicians..." These statements explicitly indicate its role in providing information for diagnosis.
No
The device description explicitly states that "AW Server is a software package delivered with off-the-shelf server-class hardware". This indicates that the device includes hardware components as part of its delivery and intended use, even if the software is the primary medical function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device deals with medical images (DICOM images) from various modalities. It's a software system for accessing, processing, and reviewing these images.
- The intended use and device description clearly state its purpose is related to radiology procedures and reviewing diagnostic evidence from images.
The device is a medical software system for image management and processing, not for analyzing biological specimens.
N/A
Intended Use / Indications for Use
AW Server is a medical software system that allows multiple users to remotely access A W applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
The device is not intended for diagnosis of mammography images. The device is not intended for diagnosis of lossy compressed images. For other images, trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient Indy as are mage as age compression ratios are consistent with clinical application.
Product codes
LLZ
Device Description
AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
The device is not intended for diagnosis of mammography images. The device is not intended for diagnosis of lossy compressed images. For other images, trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.
A W Server is a software package delivered with off-the-shelf server-class hardware that allows easy selection, review, processing and filming of multiple modality DICOM images from a variety of PC client machines, using LAN or WAN networks. It also allows user selectable loss-less and lossy compression schemes that are used in order to make a trade-off between speed and quality.
AW Server is intended to be used in a manner similar to the current GE Medical Systems A W workstation product. It will be used to create and review diagnostic evidence related to radiology procedures by trained physicians in General Purpose Radiology, Oncology, Cardiology and Neurology clinical areas.
AW Server, like Advantage Workstation 4.3, may be used with a variety of other GE software medical devices, which are cleared by FDA in their own names ..
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
multimodality DICOM images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians in General Purpose Radiology, Oncology, Cardiology and Neurology clinical areas.
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)
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
Ko 81985
SEP 2 5 2008
Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters and the border are black, contrasting with the white background. The logo is a well-known symbol representing the multinational conglomerate.
GE Medical Systems
AW Server 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.
1. Identification of submitter:
| Author (Primary contact) | US Designated Agent (2nd contact) |
|---|---|
| Stephen Slavens | Kirsten Schutz |
| DI Global RA Premarket Director | DI Quality Assurance Director |
| GE Healthcare | GE Healthcare |
| 3000 N Grandview Blvd. W706 | 3000 N Grandview Blvd. W706 |
| Waukesha, WI 53188 | Waukesha, WI 53188 |
| Tel: 262-548-4992 | Tel: 262-312-7117 |
| Fax: 262-548-4710 | Fax: 262-544-3141 |
| stephen.slavens@ge.com | kirsten.schutz@ge.com |
2. Identification of Product:
| Device name | AW Server |
|---|---|
| Classification name | PACS per 21 CFR 892.2050 |
| Owner/Operator | General Electric |
| Manfacturing site | General Electric Medical Systems SCS |
| 283, Rue de la Minière | |
| 78533 BUC Cedex France |
3. Marketed Devices
AW Server is substantially equivalent to the devices listed below:
| Model: | Advantage Workstation 4.3 |
|---|---|
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K052995 |
| Classification name: | PACS per 21 CFR 892.2050 |
| Regulatory Class: | II |
| Product Code: | LLZ |
| Model: | AquariusNET Server |
| Manufacturer: | TeraRecon, Inc. |
| 510 (k): | K012086 |
| Classification name: | PACS per 21 CFR 892.2050 |
| System, Image processing per 21 CFR 829.2020 | |
| Regulatory Class: | II |
| Product Code: | 90-LLZ, 90-LMD |
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Image /page/1/Picture/1 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.
4. Device Description :
AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
The device is not intended for diagnosis of mammography images. The device is not intended for diagnosis of lossy compressed images. For other images, trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.
A W Server is a software package delivered with off-the-shelf server-class hardware that allows easy selection, review, processing and filming of multiple modality DICOM images from a variety of PC client machines, using LAN or WAN networks. It also allows user selectable loss-less and lossy compression schemes that are used in order to make a trade-off between speed and quality.
AW Server is intended to be used in a manner similar to the current GE Medical Systems A W workstation product. It will be used to create and review diagnostic evidence related to radiology procedures by trained physicians in General Purpose Radiology, Oncology, Cardiology and Neurology clinical areas.
AW Server, like Advantage Workstation 4.3, may be used with a variety of other GE software medical devices, which are cleared by FDA in their own names ..
5. Indications for Use
AW Server is a medical software system that allows multiple users to remotely access A W applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
The device is not intended for diagnosis of mammography images. The device is not intended for diagnosis of lossy compressed images. For other images, trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient Indy as are mage as age compression ratios are consistent with clinical application.
2
Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular border. There are decorative elements resembling leaves or swirls surrounding the circle. The logo is black and white.
6. Comparison with Predicate Device
The functional features of AW Server software package are substantially equivalent to that of the following devices:
| Device Name | FDA Clearance Number |
|---|---|
| Advantage Workstation 4.3 | K052995 |
| AquariusNET Server | K012086 |
7. Adverse Effects on Health
The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:
- Software Development, Validation and Verification Process to ensure . performance to specifications, Federal Regulations and user requirements.
- Adherence to industry and international standards. .
8. Conclusions
AW Server does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the AW Server to be equivalent to predicate devices listed in section 6. GE has assessed and tested this device as a software moderate Level of Concern device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The bird is positioned above a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
SEP 2 5 2008
GE Medical Systems, LLC % Mr. Daniel W. Lehtonen Sr. Staff Engineer -- Medical Devices Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K081985
Trade/Device Name: AW Server Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 9, 2008
Received: September 10, 2008
Dear Mr. Lehtonen:
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:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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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.
forque 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
5
Indications for Use
510(k) Number (if known): Device Name: AW SERVER Indications for Use:
AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
The device is not intended for diagnosis of mammography images. The device is not intended for diagnosis of lossy compressed images. For other images, trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.
Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Arni In Whing
(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Devices 510(k) Number