510(k) · Cleared
ClearedMed-Seg, Model BTMS 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bartron Medical Imaging, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 26, 2010 as substantially equivalent to K090481 (Demasq Limited, 2009) after a 356-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Jul 26, 2010
- Review
- 356 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K896095 (1990). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 5 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 4 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 3 generations backK023476 Unipacs WorkstationUniversal Pacs, Inc. · 2003
- 2 generations backK071894 Xebra Dicom Image BrowserHx Technologies, Inc. · 2007
- 1 generation backK090481 Demasq Imaging Spftware DeviceDemasq Limited · 2009
- This deviceK092328 Med-Seg, Model BTMS 1000Bartron Medical Imaging, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −6 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −5 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −4 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −3 | K023476 | Unipacs Workstation | Universal Pacs, Inc. | 2003 | — |
| −2 | K071894 | Xebra Dicom Image Browser | Hx Technologies, Inc. | 2007 | — |
| −1 | K090481 | Demasq Imaging Spftware Device | Demasq Limited | 2009 | — |
| 0 (this device) | K092328 | Med-Seg, Model BTMS 1000 | Bartron Medical Imaging, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
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 |
|---|---|---|---|
| * | K090481 | Demasq Imaging Spftware DeviceSummary page 2…7e A GOOD IMAGE IS WORTH A THOUSAND WORDS Predicate Device DEMASQ Imaging Software, manufactured by DEMASQ Ltd of Wales, United Kingdom and cleared under 510(k) #K090481 on March 19, 2009. Intended Use I Indications for Use MED-SEG is a software device that receives medical images and data from v… | 2009 |
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.
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 16 ancestors has a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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?
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…
Read the full statement (158 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092328: Med-Seg, Model BTMS 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092328
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026