510(k) · Cleared
ClearedCurve Image
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curve Dental, Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 21, 2011 as substantially equivalent to K982422 (Eaglesoft, A Patterson Co., 1998) and 1 other predicate after a 93-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Apr 21, 2011
- Review
- 93 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K913770 (1991). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 4 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 3 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 2 generations backK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 1 generation backK083018 Centricity Pacs Web DiagnosticGe Healthcare Dynamic Imaging Solutions · 2008 · Recalled
- This deviceK110139 Curve ImageCurve Dental, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −4 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −3 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −2 | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | 23 |
| −1 | K083018 | Centricity Pacs Web Diagnostic | Ge Healthcare Dynamic Imaging Solutions | 2008 | 4 |
| 0 (this device) | K110139 | Curve Image | Curve Dental, Inc. | 2011 | — |
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? (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 |
|---|---|---|---|
| * | K982422 | Eaglesoft ChairsideSummary page 2…cleared predicate devices with regard to indications for use, performance and technological characteristics: 5 10O(k) Number: K982422 Trade Name: ChairS ide Software Application Manufacturer: EagleSoft Cla… | 1998 |
| * | K083018 | Centricity Pacs Web DiagnosticSummary page 2…: PACS Classification: Class II Regulation Number: 892.2050 Product Codes: LLZ 5 10O(k) Number: K083018 Trade Name: Centric ity PACS Web Diagnostic (Web DX) PACS Manufacturer: GE Healthcare… | 2008 |
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 20 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 4 of the 12 ancestors have a recall of any class.
- 5 other devices also cite its predicate K982422.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
CURVE IMAGE is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts, treatment plans, clinical notes, audit recording and clinical exam data. The system uses a Web-based interface and includes the editing and storage of digital images. The system is designed to be a single source solution for a dental practice. Images and data can be stored, communicated, processed and displayed…
Read the full statement (112 words)
CURVE IMAGE is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts, treatment plans, clinical notes, audit recording and clinical exam data. The system uses a Web-based interface and includes the editing and storage of digital images. The system is designed to be a single source solution for a dental practice.
Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images cannot be acquired from standard dental imaging devices, but can be uploaded directly from the user's computer. Images can be edited (e.g., resized, contrast, cropped, etc.), as well as exported.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110139: Curve Image.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110139
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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