510(k) · Cleared
ClearedXVWEB
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 Dec 20, 2013 as substantially equivalent to K112974 (Curve Dental, Inc., 2011) and 1 other predicate after a 147-day review. Its family tree reaches back 7 generations to 1991. 3 later devices descend from it.
- Decided
- Dec 20, 2013
- Review
- 147 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K913770 (1991). 13 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 5 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 4 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 3 generations backK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 2 generations backK083018 Centricity Pacs Web DiagnosticGe Healthcare Dynamic Imaging Solutions · 2008 · Recalled
- 1 generation backK112974 Picture Archiving and Communications SystemCurve Dental, Inc. · 2011
- This deviceK132342 XVWEBApteryx, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK210682 SOTA Cloud ImagingSota Precision Optics, Inc. Dba Sota Imaging · 2021
- Descendant · 2 generations on · 0 of its ownK253111 Aeka ImagingGood Methods Global, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK182815 XVWeb 3DApteryx, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −5 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −4 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −3 | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | 23 |
| −2 | K083018 | Centricity Pacs Web Diagnostic | Ge Healthcare Dynamic Imaging Solutions | 2008 | 4 |
| −1 | K112974 | Picture Archiving and Communications System | Curve Dental, Inc. | 2011 | — |
| 0 (this device) | K132342 | XVWEB | Apteryx, Inc. | 2013 | — |
| +1 | K210682 | SOTA Cloud Imaging | Sota Precision Optics, Inc. Dba Sota Imaging | 2021 | — |
| +2 | K253111 | Aeka Imaging | Good Methods Global, Inc. | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K112974 | Picture Archiving and Communications SystemSummary page 3…XVWeb . Curve Image Centricity PACS Web (K112974) Diagnostic (Web DX)… | 2011 |
| * | K083018 | Centricity Pacs Web DiagnosticSummary page 1…ulation Number: 892.2050 Product Code: LLZ Classification Panel: Radiology Devices 510(K) Number: K(083018 Trade Name: Centricity PACS Web Diagnostic (Web DX) PACS System Manufacturer: GE… | 2008 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K210682 (Sota Precision Optics, Inc. Dba Sota Imaging, 2021) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K112974.
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?
XVWeb is a Picture Archiving and Communications System (PACS) that enables dental facilities to query and access digitally stored hard and soft tissue intracral /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…
Read the full statement (174 words)
XVWeb is a Picture Archiving and Communications System (PACS) that enables dental facilities to query and access digitally stored hard and soft tissue intracral /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 database. XVWeb iscompatible 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 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/K132342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132342: XVWEB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132342
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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