510(k) · Cleared
ClearedSystem 2100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Math Solutions, LLC · LLZ System, Image Processing, Radiological
Cleared on Dec 15, 1999 after a 58-day review. The FDA summary names its predicate without a number.
- Decided
- Dec 15, 1999
- Review
- 58 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Precision View Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (428 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993530: System 2100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993530
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026