# K993530: System 2100

- Pathway: 510(k) (Traditional)
- Applicant: Math Solutions, LLC
- Decided: Dec 15, 1999 after 58 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Precision View: named in the summary without a submission number

## Indications for use
The system is intended for use by any health practitioner who has the need for any of the below functions: 1. The software may be used to display medical images. The user may adjust the contrast of the images and image process the images with an edge enhancement algorithm. The user can zoom in on a region of an image, enlarging that region on the display screen. Other image processing functions may be added in the future to allow the user to enhance some aspect of an image, such as histogram processing, spatial filtering, frequency filtering. 2. Images from the same series can be stacked to form a three dimensional model. This will allow the use of the system to reformat images in other planes, such as coronal and sagittal planes. 3. Outlining tools are provided to use the system to outline regions of interest. These outlines may be combined to define three dimensional shapes which can be viewed in three dimensional perspective views. 4. The region of interest outlines may be written back to DICOM formatted image files for export to other systems. 5. The system can be used to determine the stereotactic coordinates of a point located on an image when a stereotactic system is employed. 6. The system may be used to provide support for any stereotactic system that consists of fixed rods which can be uniquely located on CT and MRI images. 7. The system may be used to solve for the transformation between two images sets, referred to as image fusion. 8. A region of interested outlined on one image set may be transferred to a fused image set. 9. The system may be used as a front end to other systems that do not provide image fusion. An example would be outlining a region of interest on MRI scans, transferring the outlines to CT scans, and writing the outlines back into DICOM image files. Those files can be available to other systems such as a radiation therapy treatment planning system. 10. The system may be used to print hardcopy images of selected images, reformatted images, and three dimensional perspective views. 11. Image segmentation tools are provided to create three dimensional structures for viewing in three dimensional perspective views. The intention is also to provide these basic functions as a C++ object library to any party that may wish to use the library to build their own applications. Those customers will be completely responsible for the integration, testing, use of the end product that they produce, and compliance with federal and state regulations.

Source page: https://510kreport.com/device/K993530
Methodology: https://510kreport.com/methodology