510(k) · Cleared
Recalled · 2009Xoranconnect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xoran Technologies, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 7, 2008 as substantially equivalent to K072205 (Mercury Computer Systems, Inc., 2007) and 1 other predicate after a 45-day review. Its family tree reaches back 5 generations to 1995. It has been recalled once.
- Decided
- Jan 7, 2008
- Review
- 45 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K945188 (1995). 7 ancestors in all. 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 backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- 2 generations backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- 1 generation backK072205 Visage Pacs/CS, Release Version 5.0Mercury Computer Systems, Inc. · 2007
- This deviceK073306 XoranconnectXoran Technologies, 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 | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| −2 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| −1 | K072205 | Visage Pacs/CS, Release Version 5.0 | Mercury Computer Systems, Inc. | 2007 | — |
| 0 (this device) | K073306 | Xoranconnect | Xoran Technologies, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K072205 | Visage Pacs/CS, Release Version 5.0Summary page 1…redicate) Devices XoranConnect TM software is substantially equivalent to the following predicate devices: Visage PACS/CS (Mercury Computer Systems, Inc.), K072205 NovaPACS (NovaRad Corporation), K061920 XoranConnect-S10K.doc Page 11 of 12… | 2007 |
| * | K061920 | Novapacs, Novaview, Novacardio, Novaqc and NovaerSummary page 1…re is substantially equivalent to the following predicate devices: Visage PACS/CS (Mercury Computer Systems, Inc.), K072205 NovaPACS (NovaRad Corporation), K061920 XoranConnect-S10K.doc Page 11 of 12 11/20/2007 6:40 PM ===… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 3, 2009 | Not classified | Z-1577-2009 | Software design | An incorrect patient name label may appear on the screen displaying the selected patient's scan. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- None of the 7 ancestors has a recall.
- 3 other devices also cite its predicate K072205.
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?
XoranConnect is a medical imaging software system intended to display, edit, review,
store, print and distribute images acquired from imaging devices such as Computed
Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Ultrasound
(US), Nuclear Medicine (NM), and other devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073306: Xoranconnect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073306
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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