510(k) · Cleared
ClearedSidexis 4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · LLZ System, Image Processing, Radiological
Cleared on Dec 11, 2013 as substantially equivalent to K013659 (Sirona Dental Systems GmbH, 2001) and 1 other predicate after a 97-day review. Its family tree reaches back 7 generations to 1996. 1 later device descends from it.
- Decided
- Dec 11, 2013
- Review
- 97 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K954874 (1996). 42 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 6 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 5 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 4 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 3 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 2 generations backK061370 Cardiq FusionGE Healthcare · 2006
- 1 generation backK113543 ONDEMAND3DCybermed, Inc. · 2011
- This deviceK132773 Sidexis 4Sirona Dental Systems GmbH · 2013
- Descendant · cites it directly · 0 of its ownK250755 DS Core DiagnosisDentsply Sirona, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250755DS Core DiagnosisDentsply Sirona, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −6 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −5 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −4 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −3 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −2 | K061370 | Cardiq Fusion | GE Healthcare | 2006 | — |
| −1 | K113543 | ONDEMAND3D | Cybermed, Inc. | 2011 | — |
| 0 (this device) | K132773 | Sidexis 4 | Sirona Dental Systems GmbH | 2013 | — |
| +1 | K250755 | DS Core Diagnosis | Dentsply Sirona, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013659 | Modification to Sidexis Digital Radiography Imaging System | 2001 |
| Kept off the family tree | K012307 | FDA’s K012307 is Luxacore/Luxacore Dual Our reading of the summary gave K012307, FDA’s number for Luxacore/Luxacore Dual (Dmg USA, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “GALAXIS (GALILEOS family)”. Kept off the family tree. Summary page 1…ystem Classification Name: System, Image Processing, Radiological 3. PREDICATE DEVICES " SIDEXIS XG (KOI 3659) " GALAXIS cleared with (GALILEOS family K01 23070) * Cybermed On~emand3D (Ki 13543) 4. INTENDED USE SIDEXIS 4 is software that offers functions for the acquisition, adminis… | 2001 |
| * | K113543 | ONDEMAND3DSummary page 2…ARACTERISTICS Not applicable 8. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS SIDEXIS 4 offers similar functions and views as the predicate device Cybermed Onoemand3D (113543). It offers similar functions to the predicate software parts of SIDEXIS XG and GALAXIS together. All systems (SIDEXIS XG and GA… | 2011 |
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 |
|---|---|---|---|
| K250755 | DS Core Diagnosis | 2025 | 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 17 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 42 ancestors have a recall of any class.
- Of its descendants, K250755 (Dentsply Sirona, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K013659.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
SIDEXIS 4 is software that offers functions for the acquisition, administration, analysis, diagnosis, presentation and transfer of digital or digitized image data, e.g. X-ray images or video recordings, for medical use, predominantly in dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132773 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132773: Sidexis 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132773
Report an extraction error
Are you the manufacturer?
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