510(k) · Cleared
ClearedCS Orthodontic Imaging Software CS Oms Imaging Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Dental, LLC · LLZ System, Image Processing, Radiological
Cleared on Sep 12, 2012 as substantially equivalent to K043104 (Practiceworks, Inc., 2005) after a 34-day review. Its family tree reaches back 4 generations to 1993. 22 later devices descend from it.
- Decided
- Sep 12, 2012
- Review
- 34 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K930527 (1993). 5 ancestors in all. 22 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK930527 Dental LinkEscan, Inc. · 1993
- 3 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 2 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 1 generation backK043104 Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005
- This deviceK122427 CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC · 2012
- Descendant · cites it directly · 19 of its ownK131570 OrthovisionEwoosoft Co., Ltd. · 2013
- Descendant · 2 generations on · 18 of its ownK173094 OrthoVisionEwoosoft Co., Ltd. · 2017
- Descendant · 3 generations on · 17 of its ownK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- Descendant · 4 generations on · 6 of its ownK210187 Overjet Dental AssistOverjet, Inc. · 2021
- Descendant · 4 generations on · 6 of its ownK202948 EzOrthoEwoosoft Co., Ltd. · 2020
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K131570OrthovisionEwoosoft Co., Ltd. · 2013 · cites it directly19descendants
- K173094OrthoVisionEwoosoft Co., Ltd. · 2017 · 2 generations on18descendants
- K192888EzOrthoEwoosoft Co., Ltd. · 2020 · 3 generations on17descendants
- K210187Overjet Dental AssistOverjet, Inc. · 2021 · 4 generations on6descendants
- K202948EzOrthoEwoosoft Co., Ltd. · 2020 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −3 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −2 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −1 | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0 | Practiceworks, Inc. | 2005 | — |
| 0 (this device) | K122427 | CS Orthodontic Imaging Software CS Oms Imaging Software | Carestream Dental, LLC | 2012 | — |
| +1 | K131570 | Orthovision | Ewoosoft Co., Ltd. | 2013 | — |
| +2 | K173094 | OrthoVision | Ewoosoft Co., Ltd. | 2017 | — |
| +3 | K192888 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| +4 | K210187 | Overjet Dental Assist | Overjet, Inc. | 2021 | — |
| +4 | K202948 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0Summary page 1…6. Device Description CS Orthodontic Imaging and CS OMS Imaging software is a modification of currently legally marketed Kodak Orthodontic and OMS Imaging v8.0 software (K043 104). The software is intended for installation at orthodontic or oral surgery clinics and offices on general purpose off-the-shelf c… | 2005 |
What descends from it? (22)
See all 222 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 19 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K131570 (Ewoosoft Co., Ltd., 2013) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K043104.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
CS Orthodontic Imaging and CS OMS Imaging software is indicated for use by orthodontists or oral maxillofacial surgeons and their clinical staff in storing and organizing images, including digital photographs and x-rays. The device includes the capability to trace a digital cephalometric radiograph, analyze the measurements taken and make growth or surgical predictions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122427: CS Orthodontic Imaging Software CS Oms Imaging Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122427
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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