510(k) · Cleared
ClearedPicture Archiving and Communications System
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 Oct 20, 2011 as substantially equivalent to K982422 (Eaglesoft, A Patterson Co., 1998) and 1 other predicate after a 15-day review. Its family tree reaches back 6 generations to 1991. 7 later devices descend from it.
- Decided
- Oct 20, 2011
- Review
- 15 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. 7 later devices descend from it, 4 citing it directly.
- 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 deviceK112974 Picture Archiving and Communications SystemCurve Dental, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK132342 XVWEBApteryx, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK210682 SOTA Cloud ImagingSota Precision Optics, Inc. Dba Sota Imaging · 2021
- Descendant · 3 generations on · 0 of its ownK253111 Aeka ImagingGood Methods Global, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251880 Archy Dental ImagingArchy Dental, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK220684 Oryx Cloud ImagingOryx Dental Software, Inc. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K132342XVWEBApteryx, Inc. · 2013 · cites it directly3descendants
- K210682SOTA Cloud ImagingSota Precision Optics, Inc. Dba Sota Imaging · 2021 · 2 generations on1descendant
- K253111Aeka ImagingGood Methods Global, Inc. · 2026 · 3 generations on0descendants
- K251880Archy Dental ImagingArchy Dental, Inc. · 2025 · cites it directly0descendants
- K220684Oryx Cloud ImagingOryx Dental Software, Inc. · 2022 · cites it directly0descendants
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) | K112974 | Picture Archiving and Communications System | Curve Dental, Inc. | 2011 | — |
| +1 | K132342 | XVWEB | Apteryx, Inc. | 2013 | — |
| +2 | K210682 | SOTA Cloud Imaging | Sota Precision Optics, Inc. Dba Sota Imaging | 2021 | — |
| +3 | K253111 | Aeka Imaging | Good Methods Global, Inc. | 2026 | — |
| +1 | K251880 | Archy Dental Imaging | Archy Dental, Inc. | 2025 | — |
| +1 | K220684 | Oryx Cloud Imaging | Oryx Dental Software, Inc. | 2022 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K982422 | Eaglesoft ChairsideSummary page 1…ng FDA cleared predicate devices with regard to indications for use, performance and technological characteristics: 510(k) Number: K982422 Trade Name: ChairSide Software Application Manufacturer: EagleSoft Classifica… | 1998 |
| * | K083018 | Centricity Pacs Web DiagnosticSummary page 2…Product Codes: LLZ Page I of 7 5 10(k) Number: K083018 Trade Name: Centricity PACS Web Diagnostic (Web DX) PACS Manufacturer: GE Healthcare Dynamic Imag… | 2008 |
What descends from it? (7)
4 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 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.
- Of its descendants, K132342 (Apteryx, Inc., 2013) has gone furthest, with 3 descendants of its own.
- 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 in a form of digital images. The system uses a Web-based interface and includes acquisition, editing and storage of digital images. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images can be acquired from standard dental imaging devices, or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast, rotated, etc.), as well as exported. The system is designed to provide images for diagnostic use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112974 · printed Nov 5, 2026
Cite this page
510(k) Report. “K112974: Picture Archiving and Communications System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K112974
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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