(53 days)
No
The description focuses on automating manual measurements using existing software platforms and principles of operation, with no mention of AI or ML terms or concepts.
No
The device calculates the volume of anatomical structures from CT images, which is a diagnostic function, not a therapeutic one. It analyzes existing images rather than directly treating or preventing a disease.
No
The device calculates the volume of 3D structures from CT images. While it operates on a "Diagnostic Workstation," its function is measurement automation rather than diagnosing conditions.
Yes
The device is described as a "software package" to be used on an existing workstation, and it explicitly states there is "no energy source associated with this package in and of itself," indicating it is purely software running on separate hardware.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to calculate the volume of structures from CT images. While the images themselves are generated in vivo (within the body), the analysis of these images to derive quantitative information (volume) is performed in vitro (outside the body, on the workstation). This analysis is used to "automate manual measurements and estimates that are currently made regarding the measure of volume of anatomy and pathology imaged with computed tomography." This suggests the output is used for diagnostic purposes, aiding in the assessment of anatomical structures or pathological conditions.
- Device Description: It's a software package used on a diagnostic workstation (K913770, which is also a predicate device). The software processes images obtained from a CT scanner.
- Input Imaging Modality: CT images are used as input. These images are a form of diagnostic data.
- Predicate Device: The predicate device (K913770; Advantage Windows 3D Option) is a diagnostic workstation and a related software option for image processing and analysis. This further supports the diagnostic nature of the current device.
While the device itself doesn't directly interact with biological samples, its function is to process and analyze diagnostic imaging data to provide quantitative information that is used in the diagnostic process. This aligns with the definition of an IVD, which includes devices used to examine specimens derived from the human body to provide information for diagnostic purposes. In this case, the "specimen" is the CT image data, which is derived from the patient's body.
Therefore, the Advantage Windows Tissue Volume Option, by providing quantitative volume measurements from diagnostic CT images for the assessment of anatomy and pathology, fits the description of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Advantage Windows Tisue Volume Option is intended to calculate the volume of any three dimensional structure from a set of CT images. The images are displayed and measured on the CT/MR Advantage Windows Diagnostic Workstation (K913770). The Tissue Volume Option will automate manual measurements and estimates that are currently made regarding the measure of volume of anatomy and pathology imaged with computed tomography.
Product codes
Not Found
Device Description
The device is a software package to be used on the Advantage Windows Workstation (K913770).
Design: The design is based on the same software platform as used for Advantage Windows 3D (VoxTool) and will operate on the Advantage Windows Operating System. The workstation hardware required for operation will be the Sun Sparc 20, Mod 40 or higher. The images used to measure volume can be captured by any CT scanner and transferred to Advantage Windows workstation by DICOM or Ethernet.
Energy Source and Exposure Levels: There is no energy source associated with this package in and of itself. However, the energy source used to make the image being analyzed is the same used to take standard CT diagnostic images.
Principals of Operation: The same as Advantage Windows 3D.
Features: To calculate the volume of areas of a CT image selected by the operator.
Accessories: None
Marketing History:
The Advantage Windows Tissue Volume Option is substantially equivalent to the currently marketed Advantage Windows 3D Option (K913770).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
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
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
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Summary of Safety & Effectiveness
Product Identification:
Name: Advantage Windows Tissue Volume Option
OCT 1 8 1996
Manufacturer: General Electric Medical Systems 16800 W. Ryerson Road New Berlin, WI 53151
Distributor: Same as Manufacturer
Indications for Use:
Advantage Windows Tisue Volume Option is intended to calculate the volume of any three dimensional structure from a set of CT images. The images are displayed and measured on the CT/MR Advantage Windows Diagnostic Workstation (K913770). The Tissue Volume Option will automate manual measurements and estimates that are currently made regarding the measure of volume of anatomy and pathology imaged with computed tomography.
Device Description:
The device is a software package to be used on the Advantage Windows Workstation (K913770).
Design: The design is based on the same software platform as used for Advantage Windows 3D (VoxTool) and will operate on the Advantage Windows Operating System. The workstation hardware required for operation will be the Sun Sparc 20, Mod 40 or higher. The images used to measure volume can be captured by any CT scanner and transferred to Advantage Windows workstation by DICOM or Ethernet.
Energy Source and Exposure Levels: There is no energy source associated with this package in and of itself. However, the energy source used to make the image being analyzed is the same used to take standard CT diagnostic images.
Principals of Operation: The same as Advantage Windows 3D.
Features: To calculate the volume of areas of a CT image selected by the operator.
Accessories: None
Marketing History:
The Advantage Windows Tissue Volume Option is substantially equivalent to the currently marketed Advantage Windows 3D Option (K913770).
Adverse Effects on Health:
The package itself will not have any adverse affects on health. This tool measures and displays the volume of an outlined image. The oulining is in the hands of the operator who can choose to accept or reject the outlined region and then select to use that data to compare againt earlier images from other patients.
Conclusions:
The Advantage Windows Tissue volume Option enhances the current Advantage Windows 3D package by automaiting volumetric measurements that are currently being made manually using the measure distance tools of the 3D package. It is substantially equivalent to the Advantage Windows 3D package in design, construction, principle of operation, and features.