(90 days)
Not Found
No
The summary describes image registration and comparison software without mentioning AI or ML, and the "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device aids in diagnostic imaging and radiation therapy planning by processing and registering medical images, but it does not directly treat or prevent a disease or condition. Its function is for image comparison and analysis, which supports clinical decision-making rather than providing therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for use in diagnostic radiology". Additionally, the "Device Description" mentions "a use of previously recorded diagnostic information from follow-up studies."
Yes
The device is described as a "software option for the Advantage Windows Workstation" and its function is image comparison and registration, which are software-based processes. There is no mention of any hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this software is used for comparing and registering 3D images from CT and MR scans of a patient. It processes images of the patient, not specimens taken from the patient.
- The examples of application are all related to image analysis and visualization for diagnostic and planning purposes. None of the examples involve testing biological samples.
The device is a medical image processing and analysis software intended for use in diagnostic radiology and radiation therapy planning.
N/A
Intended Use / Indications for Use
Advantage Windows Fusion provides an easy means for comparison of three dimensional (3D) images from computed tomography (CT) and magnetic resonance (MR). It allows 3D registration between two volumetric acquisitions, which may come from different acquisition modalities (CT/MR), for use in diagnostic radiology or radiation therapy planning.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
Advantage Windows Fusion is a software option for the Advantage Windows Workstation that provides easy comparison of three dimensional (3D) images from computed tomography (CT) and magnetic resonance (MR). It allows 3D registration between two volumeric acquisitions, which may come from different acquisition modalities ( CT / MR).
Application examples include:
- a use of previously recorded diagnostic information from follow-up studies.
- o combination of CT and MR for better volume definition.
- · definition of a volume of interest within one patient model,
- with automatic report in the other model ..
- " fusion of functional and anatomical images.
- a medical education.
- 6 better communication of clinical results to referring physicians.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (CT) and magnetic resonance (MR)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
diagnostic radiology or radiation therapy planning.
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)
The AW Fusion option will be fully verified/validated per the program test plans
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/4 description: The image shows a black and white drawing of a round object. The object appears to be a sphere with an uneven surface. The surface has a mottled texture, with light and dark patches distributed across it.
GE Medical Systems P.O. Box 414, W-709 Milwaukee, WI 53201 USA
DEC 15 1998
ADVANTAGE WINDOWS FUSION 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:
Larry A. Kroger, Ph.D. Senior Regulatory Program Manager Telephone: (414) 544-3894 Date Prepared: September 15, 1997 (revised December 11, 1998)
Identification of Product:
| Name : | Advantage Windows Fusion |
|---|---|
| Manufacturer : | General Electric Medical Systems |
| 283, rue de la Miniere | |
| 78533 Buc Cedex, FRANCE | |
| Distributor : | General Electric Medical Systems, Milwaukee, WI |
Marketed Devices:
The Advantage Windows Fusion is substantially equivalent to the device listed below:
| Model: | Fusion and Registration feature of Advance Analysis Software |
|---|---|
| Manufacturer: | General Electric Medical Systems, Milwaukee, WI |
| 510(k) #: | K941223 |
Device Description:
Advantage Windows Fusion is a software option for the Advantage Windows Workstation that provides easy comparison of three dimensional (3D) images from computed tomography (CT) and magnetic resonance (MR). It allows 3D registration between two volumeric acquisitions, which may come from different acquisition modalities ( CT / MR).
Application examples include:
- a use of previously recorded diagnostic information from follow-up studies.
- o combination of CT and MR for better volume definition.
- · definition of a volume of interest within one patient model,
- with automatic report in the other model ..
- " fusion of functional and anatomical images.
- a medical education.
- 6 better communication of clinical results to referring physicians.
1
Image /page/1/Picture/3 description: The image shows a dark, round object with a slightly irregular surface. The object appears to be solid and opaque, with no visible internal details. The lighting on the object suggests a smooth, reflective surface, with a highlight on the upper right side. The background is plain and white, which helps to isolate the object and emphasize its shape and texture.
GE Medical Systems P.O. Box 414, W-709 Milwaukee, WI 53201 USA
Indications for Use :
Advantage Windows Fusion provides an easy means for comparison of three dimensional (3D) images from computed tomography (CT) and magnetic resonance (MR). It allows 3D registration between two volumetric acquisitions, which may come from different acquisition modalities (CT/MR), for use in diagnostic radiology or radiation therapy planning.
Comparison with Predicate:
The Advantage Windows Fusion option allows comparison of 3D images similar to the comparison of 2D images performed with the Fusion and Registration feature of the Advanced Analysis software. This product provides 3D composite images comparable to the 2D composite images produced by the predicate device .
Summary of studies :
The AW Fusion option will be fully verified/validated per the program test plans
Conclusions :
The Advantage Windows Fusion option provides 3D information that allows comparison of volumetric acquisitions from different studies and modalities. The potential hazards are controlled by a risk management plan including:
- · a Hazard Analysis/Risk Management Summary
- · a Software Development and Validation Process
- · a Software Verification Plan
This product provides images comparable to the predicate device.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 1998
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414 , W-709 Milwaukee, WI 53201
Re:
K983256 Advantage Windows (AW) Fusion Dated: September 15, 1998 Received: September 16, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Dr. Kroger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
J.J.T.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: Advantage Windows Fusion
Indications for Use
Advantage Windows Fusion provides an easy means for comparison of three dimensional (3D ) images from computed tomography ( CT ) and magnetic resonance ( MR). It allows 3D registration between two volumetric acquisitions, which may come from different acquisition modalities ( CT / MR), for use in diagnostic radiology or radiation therapy planning.
(PLESE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801-109) |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K983256 |
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