510(k) · Cleared
ClearedDemasq Imaging Spftware Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Demasq Limited · LLZ System, Image Processing, Radiological
Cleared on Mar 19, 2009 as substantially equivalent to K052545 (Infinitt Co., Ltd., 2005) and 1 other predicate after a 23-day review. Its family tree reaches back 6 generations to 1990. 1 later device descends from it.
- Decided
- Mar 19, 2009
- Review
- 23 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K896095 (1990). 15 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 4 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 3 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 2 generations backK023476 Unipacs WorkstationUniversal Pacs, Inc. · 2003
- 1 generation backK071894 Xebra Dicom Image BrowserHx Technologies, Inc. · 2007
- This deviceK090481 Demasq Imaging Spftware DeviceDemasq Limited · 2009
- Descendant · cites it directly · 0 of its ownK092328 Med-Seg, Model BTMS 1000Bartron Medical Imaging, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K092328Med-Seg, Model BTMS 1000Bartron Medical Imaging, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −5 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −4 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −3 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −2 | K023476 | Unipacs Workstation | Universal Pacs, Inc. | 2003 | — |
| −1 | K071894 | Xebra Dicom Image Browser | Hx Technologies, Inc. | 2007 | — |
| 0 (this device) | K090481 | Demasq Imaging Spftware Device | Demasq Limited | 2009 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (2)
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 |
|---|---|---|---|
| * | K052545 | Infinitt G3 PacsSummary page 1…al Product code: LLZ Device Classification: 892.2050 Predicate Device: 21 CFR 807. 92(a)(3) 510(k) Number K052545 K071894 Device Classification Name system, image processing, system, image processing,… | 2005 |
| * | K071894 | Xebra Dicom Image BrowserSummary page 1…LLZ Device Classification: 892.2050 Predicate Device: 21 CFR 807. 92(a)(3) 510(k) Number K052545 K071894 Device Classification Name system, image processing, system, image processing,… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092328 | Med-Seg, Model BTMS 1000 | 2010 | 0 |
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 19 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K092328 (Bartron Medical Imaging, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K052545.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
DEMASQ Imaging Software DeviceTM 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. Only pre-processed…
Read the full statement (139 words)
DEMASQ Imaging Software DeviceTM 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.
Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.
Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090481: Demasq Imaging Spftware Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090481
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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