510(k) · Cleared
ClearedDentrix Ascend Imaging
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Realcloud Imaging, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 7, 2015 as substantially equivalent to K112974 (Curve Dental, Inc., 2011) after a 39-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Jul 7, 2015
- Review
- 39 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913770 (1991). 13 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK151438 Dentrix Ascend ImagingRealcloud Imaging, Inc. · 2015
View 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) | K151438 | Dentrix Ascend Imaging | Realcloud Imaging, Inc. | 2015 | — |
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 |
|---|---|---|---|
| * | K112974 | Picture Archiving and Communications SystemSummary page 4…o the following FDA cleared predicate device with regard to indications for use, performance and technological characteristics: 510(k) Number: K112974 Trade Name: Curve Image Manufacturer: Curve Dental, Inc. Classification Name: Picture Archiving and Co… | 2011 |
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 24 years and passes through 7 companies; a new generation was cleared every 3.7 years on median.
- 4 of the 13 ancestors have a recall of any class.
- 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. 2015, 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?
Dentrix Ascend Imaging is a web-based Dental Picture Archiving and Communications Systems (PACS), i.e. dental imaging software, that enables dental care facilities to acquire, process, edit, and enhance dental images. Dentrix Ascend Imaging provides a web-based interface for image acquisition and management of images which are used in the field of Dentistry and when operated by dental professionals who are responsible for providing dental care. Images…
Read the full statement (168 words)
Dentrix Ascend Imaging is a web-based Dental Picture Archiving and Communications Systems (PACS), i.e. dental imaging software, that enables dental care facilities to acquire, process, edit, and enhance dental images.
Dentrix Ascend Imaging provides a web-based interface for image acquisition and management of images which are used in the field of Dentistry and when operated by dental professionals who are responsible for providing dental care.
Images can be acquired from dental image acquisition devices and/or consumer imaging devices such as color digital cameras. Previously acquired images or volumes can be selected for upload directly from the user's computer.
Supported images include intraoral and extraoral dental x-rays/volumes and intraoral and extraoral color images produced by intraoral video or consumer digital cameras.
Dentrix Ascend Imaging is used for diagnostic purposes in the field of dentistry. Dentrix Ascend Imaging is not intended for diagnostic use on a mobile display.
Images can be edited/enhanced (e.g. zoomed, contrast adjusted, inverted, annotated, rotated, filtered, etc...) as well as exported to standard image file formats.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151438: Dentrix Ascend Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151438
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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