510(k) · Cleared
ClearedXR-Express
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Mexico Software, Inc. · LLZ System, Image Processing, Radiological
Cleared on Oct 15, 2008 as substantially equivalent to K063221 (Nexsys Electronics, Inc., 2006) after a 62-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Oct 15, 2008
- Review
- 62 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945188 (1995). 11 ancestors in all, the oldest K864854 (1987). No later device cites it as a predicate yet.
- Root · 5 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 4 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 3 generations backK982535 Insight Diagnostic Imaging WorkstationNeo Imagery Technologies, Inc. · 1998
- 2 generations backK990241 Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore…Accuimage Diagnostics Corp. · 1999
- 1 generation backK063221 Medweb Advanced 3D Web PacsNexsys Electronics, Inc. · 2006
- This deviceK082336 XR-ExpressNew Mexico Software, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −4 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −3 | K982535 | Insight Diagnostic Imaging Workstation | Neo Imagery Technologies, Inc. | 1998 | — |
| −2 | K990241 | Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze… | Accuimage Diagnostics Corp. | 1999 | — |
| −1 | K063221 | Medweb Advanced 3D Web Pacs | Nexsys Electronics, Inc. | 2006 | — |
| 0 (this device) | K082336 | XR-Express | New Mexico Software, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 3 | 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 |
|---|---|---|---|
| * | K063221 | Medweb Advanced 3D Web PacsSummary page 2…ng FDA cleared predicate device with regard to indications for use, performance and technological characteristics: 510(k) Number: K063221 Trade Name: Advanced 3D Web PACSTM Manufacturer: Nexsys Electronics, Inc. DBA Medweb LL… | 2006 |
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 13 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- None of the 11 ancestors has a 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. 2008, 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?
XR-EXpress is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. XR-EXpress is for hospitals, imaging centers, nursing homes, radiologist reading practices, and any user who requires and is granted access to patient image, demographic, and report information.…
Read the full statement (112 words)
XR-EXpress is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. XR-EXpress is for hospitals, imaging centers, nursing homes, radiologist reading practices, and any user who requires and is granted access to patient image, demographic, and report information.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082336 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082336: XR-Express.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082336
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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