(15 days)
No
The document describes a review station for multi-modality images with basic processing capabilities, and there is no mention of AI, ML, or related concepts.
No
The device is described as a "review station" for multi-modality images, used by a physician for diagnosis, not for providing therapy.
No
The device is described as a "review station" that processes images from diagnostic systems, and its output (filmed images) "may be used as an element for diagnosis" when interpreted by a trained physician. It does not perform the diagnosis itself.
No
The device description explicitly states it is a "review station" and mentions "filming" and "media interchange," which strongly implies the presence of hardware components beyond just software.
Based on the provided information, the Advantage Workstation 4.1 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Advantage Workstation 4.1 Function: The description clearly states that the Advantage Workstation 4.1 is a "review station" for "multi-modality images from a variety of diagnosis imaging systems." It processes and displays images generated by medical imaging equipment (CT, MR, X-ray, etc.).
- No Specimen Analysis: There is no mention of the device analyzing biological specimens. Its function is centered around the manipulation and display of medical images.
Therefore, the Advantage Workstation 4.1 falls under the category of medical imaging software or a picture archiving and communication system (PACS) component, not an IVD.
N/A
Intended Use / Indications for Use
The Advantage Windows Workstation 4.1 is a review station which allows easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis.
Product codes
90 LLZ
Device Description
Advantage Workstation 4.1 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as a basis for a diagnosis.
The AW 4.1 is positioned to be the system of choice for all users of CT, MR. Vascular Xray, Cardiac Xray, Digital Xray, PET or even PET/CT systems, MG, NM, US, SR.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, Vascular Xray, Cardiac Xray, Digital Xray, PET, PET/CT, MG, NM, US, SR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / Radiology Department
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)
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
General Electric Medical Systems
FEB 2 8 2002
Advantage Workstation 4.1 510 (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: November 22nd, 2001
2. Identification of Product:
| Device name | Advantage Workstation 4.1 | Advantage Workstation 4.1 |
|---|---|---|
| Classification name | PACS per 21CFR Section 892 2050 | PACS per 21CFR Section 892 205 |
| Manufacturer/ | ||
| Distributor | General Electric Medical Systems | |
| 283, Rue de la Minière | ||
| 78533 BUC Cedex France | General Electric Medical Systems | |
| 800E. Business Center Drive | ||
| Mount Prospect, IL 60056 | ||
| USA |
3. Marketed Devices
Advantage Workstation is substantially equivalent to the devices listed below:
| Model: | Advantage Windows Review Workstation |
|---|---|
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K960613 |
Device Description :
Advantage Workstation 4.1 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as a basis for a diagnosis.
The AW 4.1 is positioned to be the system of choice for all users of CT, MR. Vascular Xray, Cardiac Xray, Digital Xray, PET or even PET/CT systems, MG, NM, US, SR.
1
The GE Advantage Workstation 4.1 support the following Sun stations:
- . Ultra 60
- Dual processor 2x450MHz .
- . Dual UltraSPARC-II* CPU
- 1 GB RAM (expandable to 2GB) .
- . Two 36 GB internal disc
- 644 MB Internal CD writer (16x write/40x read). .
- . UltraSparc 80
- QUAD Processor 4X450 MHz .
- Ouad UltraSPARC-II* CPU .
- . 2 GB RAM (expandable to 4 GB)
- Two 36 GB internal disc internal disc .
- 644 MB Internal CD writer (12x write/40x read). .
- Monitors specifications .
- SONY* Trinitron Color Monitor .
- SUN Flat Panel Monitor 18.1 LCD .
Advantage Workstation 4.1 supports the following image networking:
- Standard 10/100 Base-T Ethernet .
The GE Advantage Workstation 4.1 is designed and produced by GE Medical Systems and has been previously submitted to PMN (K913770, K942120, K960613).
5. Indications for Use
The Advantage Windows Workstation 4.1 is a review station which allows easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis.
6. Comparison with Predicate Device
The GE Advantage Workstation 4.1 is substantially equivalent to the following workstation:
Advantage Windows Review Workstation
Manufacturer: GE Medical Systems
510(k): K960613
Both of these workstations allow easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.
2
7. Conclusions
Advantage Workstation 4.1 brings additional features in order to integrate seamlessly into the Radiology Department Workflow.
The entire potential new hazards has been studied and controlled by a Risk Management Plan:
- A hazard analysis/ Risk Management Summary .
- A software development and validation process .
- A software verification plan .
Advantage Workstation 4.1 provides images comparable to the predicate device.
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Image /page/3/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text around the perimeter is not entirely clear but appears to be the name of an organization or agency. The central symbol consists of three curved lines that resemble a stylized bird or wing design. The overall impression is that of an official emblem or logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2002
General Electric Medical Systems % Mr. Wolfram Gmelin Technical Manager TÜV Rheinland of North America 12 Commerce Road NEWTON CT 06470
Re: K020483
Trade/Device Name: Advantage Workstation 4.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: February 1, 2002 Received: February 13, 2002
Dear Mr. Gmelin:
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.
4
This letter will allow you to begin marketing your device.
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
Page 2
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Image /page/5/Picture/0 description: The image shows the words "Attachment 1" written in a handwritten font. The text is oriented diagonally from the bottom left to the top right of the image. The word "Attachment" is written in a larger font size than the number "1".
STATEMENT OF INTENDED USE
510(k) Number (if known): KC20483
Device name: Advantage Workstation 4.1
Indication For Use:
The Advantage Workstation 4.1 is a review station, which allows easy selection, The Advantage Tronicalor - The Change of multi-modality images from a review, processing, himing and systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel G. Ayres
(Division Sim Division in to more to ans in 510kr Numner
Prescription Use _ (Per 21 CFR 801.109) -OR-
Over-The-Counter Use _