510(k) · Cleared
ClearedXebra Dicom Image Browser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hx Technologies, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 16, 2007 as substantially equivalent to K023476 (Universal Pacs, Inc., 2003) and 1 other predicate after a 38-day review. Its family tree reaches back 5 generations to 1990. 2 later devices descend from it.
- Decided
- Aug 16, 2007
- Review
- 38 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K896095 (1990). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 4 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 3 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 2 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 1 generation backK023476 Unipacs WorkstationUniversal Pacs, Inc. · 2003
- This deviceK071894 Xebra Dicom Image BrowserHx Technologies, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK090481 Demasq Imaging Spftware DeviceDemasq Limited · 2009
- Descendant · 2 generations on · 0 of its ownK092328 Med-Seg, Model BTMS 1000Bartron Medical Imaging, Inc. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −4 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −3 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −2 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −1 | K023476 | Unipacs Workstation | Universal Pacs, Inc. | 2003 | — |
| 0 (this device) | K071894 | Xebra Dicom Image Browser | Hx Technologies, Inc. | 2007 | — |
| +1 | K090481 | Demasq Imaging Spftware Device | Demasq Limited | 2009 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K023476 | Unipacs WorkstationSummary page 1…Classification Name: PACS (per 21 CFR 892.2050), LLZ, Class II Substantially Equivalent to both: UniPACS Workstation eFilm Workstation (K023476) (KO12211) Universal PACS, Inc. eFilm Medical Inc. 127 Albert Hart Dri… | 2003 |
| * | K012211 | Efilm Workstation | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090481 | Demasq Imaging Spftware Device | 2009 | 1 |
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 17 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K090481 (Demasq Limited, 2009) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K023476.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Xebra DICOM Image Browser TM is a software application that is used for viewing medical images. The Xebra Image Viewer receives digital images and data from various 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 are stored, communicated, processed and displayed on the local disk of a workstation and/or across…
Read the full statement (200 words)
Xebra DICOM Image Browser TM is a software application that is used for viewing medical images. The Xebra Image Viewer receives digital images and data from various 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 are stored, communicated, processed and displayed on the local disk of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. Inaddition, the Xebra Image Viewer can be integrated with an institution's existing HIS, RIS, EMR, or EHR for a fully integrated electronic patient record. Typical users of the Xebra Image Viewer are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071894 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071894: Xebra Dicom Image Browser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071894
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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