# K092328: Med-Seg, Model BTMS 1000

- Pathway: 510(k) (Abbreviated)
- Applicant: Bartron Medical Imaging, Inc.
- Decided: Jul 26, 2010 after 356 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
Longest line of descent: 7 generations back to K896095 (1990). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090481: Demasq Imaging Spftware Device, Demasq Limited (2009) Summary page 2.

## Indications for use
MED-SEG is a software device that receives medical images and data from various imaging sources (including but not limited to CT, MR, US, RF units), computed and direct radiographic devices, and secondary capture devices, (scanners, imaging gateways or imaging sources). Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. In addition to general PACS use, this system can be used by trained professionals (e.g. physicians, radiologists, nurses, medical technicians, and assistants) to separate 2D images into "digitally related" sections or regions that, after colorization, can be individually labeled by the user. These images can be used to find appropriate window/level settings, to facilitate report generation and communication, or for other uses. These processed images should not be used for primary image diagnosis. Only DICOM "for presentation" uncompressed or non-lossy compressed images can be used on an FDA cleared or approved monitor for primary image diagnosis in mammography.

Source page: https://510kreport.com/device/K092328
Methodology: https://510kreport.com/methodology