510(k) · Cleared
ClearedXVWeb 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apteryx, Inc. · LLZ System, Image Processing, Radiological
Cleared on Nov 30, 2018 as substantially equivalent to K132342 (Apteryx, Inc., 2013) after a 58-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Nov 30, 2018
- Review
- 58 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K913770 (1991). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 6 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 5 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 4 generations backK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 3 generations backK083018 Centricity Pacs Web DiagnosticGe Healthcare Dynamic Imaging Solutions · 2008 · Recalled
- 2 generations backK112974 Picture Archiving and Communications SystemCurve Dental, Inc. · 2011
- 1 generation backK132342 XVWEBApteryx, Inc. · 2013
- This deviceK182815 XVWeb 3DApteryx, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −7 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −6 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −5 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −4 | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | 23 |
| −3 | K083018 | Centricity Pacs Web Diagnostic | Ge Healthcare Dynamic Imaging Solutions | 2008 | 4 |
| −2 | K112974 | Picture Archiving and Communications System | Curve Dental, Inc. | 2011 | — |
| −1 | K132342 | XVWEB | Apteryx, Inc. | 2013 | — |
| 0 (this device) | K182815 | XVWeb 3D | Apteryx, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K132342 | XVWEBSummary page 4…Akron, OH 44308 FDA Registration Number: 3007350723 4. Predicate Device Information The predicate device is XVWeb, K132342, date of concurrence: December 20, 2013. 5. Labeling and Intended Use Labeling No changes to t… | 2013 |
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 27 years and passes through 7 companies; a new generation was cleared every 3.8 years on median.
- 4 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K132342.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
XVWeb 3D is a Picture Archiving and Communications System (PACS) that enables dental facilities to query and access digitally stored hard and soft tissue intraoral /extraoral radiological images using an internet/web browser. A web-based interface provides users the needed functionality to display patient images and studies in commercially available web browsers. Patient images/studies can be accessed by users locally within the system or across a…
Read the full statement (179 words)
XVWeb 3D is a Picture Archiving and Communications System (PACS) that enables dental facilities to query and access digitally stored hard and soft tissue intraoral /extraoral radiological images using an internet/web browser.
A web-based interface provides users the needed functionality to display patient images and studies in commercially available web browsers. Patient images/studies can be accessed by users locally within the system or across a wide-area network at distributed locations.
Acquisition can be included via integration with a DICOM-compatible Imaging and/or PACS system configured to forward images to the XVWeb 3D database. XVWeb 3D is compatible with programs that run on standard "off-the-shelf" personal computers, business computers, and servers running standard operating systems.
The system allows users to: manipulate (e.g. rotate, flip, etc.); enhance (e.g. increase or decrease brightness/contrast, gamma correction); add labels (e.g. measurements, lines, arrows, etc.), annotations to patient images/studies and other relevant operations for diagnostic purposes.
XVWeb 3D is designed for medium to large dental practices and is intended for trained dental professionals and technicians to access, manipulate, and enhance dental images for diagnostic purposes only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182815: XVWeb 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182815
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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