(167 days)
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No
The description focuses on standard image processing techniques (Time Intensity Curves, parametric images) and does not mention AI, ML, or related concepts.
No
The device provides information for diagnosis and is used for post-processing of images, not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" states that the software provides "clinical information for diagnosis purposes," and the "Device Description" explicitly says, "The purpose is to provide Time Intensity Curves and parametric images that provide clinical information for diagnosis purposes."
Yes
The device is described as a "software module" and a "functional Imaging software package" that operates on existing CT and MR datasets. It does not mention any accompanying hardware components or modifications to the existing GE CT and MR Systems.
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 FuncTool software processes and analyzes medical images (CT and MR) acquired from the patient's body. It does not perform tests on biological samples in vitro.
- Intended Use: The intended use is to provide supplemental information from medical images for diagnosis purposes. This is a function of medical imaging software, not an IVD.
Therefore, the FuncTool software falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FuncTool option to the Advantages Windows workstation is a software module that provides supplemental information to those images extracted from CT and MR temporal datasets.
Product codes
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Device Description
FuncTool is a functional Imaging software package which allows to display the temporal Single or multi-slice datasets, with equally variation in dynamic CT and MR datasets. spaced time intervals are used for input. The purpose is to provide Time Intensity Curves and parametric images that provide clinical information for diagnosis purposes. This software is used during post-processing of MR and CT images on GE's CT and MR Systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters and numbers. The sequence reads 'K96 0265'. The characters are written in a bold, somewhat irregular style, giving them a distinct, hand-drawn appearance. The numbers are clearly distinguishable, and the overall impression is that of a label or identifier.
GE Medical Systems
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
SUMMARY OF INFORMATION RESPECTING SAFETY AND EFFECTIVENESS
January 12, 1996
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
| Contact: | Lar |
|---|---|
| Ph |
rry A. Kroger, Ph.D. one: 414-544-3894 414-544-3863 Fax:
Advantage Windows with FuncTool Option Product: CT/MR Accessorv Manufactured by GE Medical Systems - Europe, Buc, France Distributed by GE Medical Systems, Milwaukee, WI
Indications for Use 1)
The FuncTool option to the Advantages Windows workstation is a software module that provides supplemental information to those images extracted from CT and MR temporal datasets.
2) Device Description
FuncTool is a functional Imaging software package which allows to display the temporal Single or multi-slice datasets, with equally variation in dynamic CT and MR datasets. spaced time intervals are used for input. The purpose is to provide Time Intensity Curves and parametric images that provide clinical information for diagnosis purposes. This software is used during post-processing of MR and CT images on GE's CT and MR Systems.
3) Marketing History
This software is presently being marketed as the Multiple Region of Interest (MIRÓI) function in the Signa MR Systems 510(k) K913475. FuncTool automates what is presently done manually.
4) Comparison with Predicate
The use of the FuncTool Option does not result in any additional potential hazards when compared to previously marketed devices.
5) Conclusions
It is the opinion of GE that the FuncTool Option is substantially equivalent to the Advantage Windows Diagnostic Workstation (K913770) and Signa Advantage (K913475) . The FuncTool Option does not include any new indications for use, nor does use of this device result in any new potential hazards.