510(k) · Cleared
ClearedOrtomed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infomed Servicios Informaticos S.L. · LLZ System, Image Processing, Radiological
Cleared on Aug 5, 2014 as substantially equivalent to K110430 (Patterson Dental Supply, Inc., 2011) and 1 other predicate after a 452-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it.
- Decided
- Aug 5, 2014
- Review
- 452 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K930527 (1993). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK930527 Dental LinkEscan, Inc. · 1993
- 4 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 3 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 2 generations backK043104 Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005
- 1 generation backK122427 CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC · 2012
- This deviceK131348 OrtomedInfomed Servicios Informaticos S.L. · 2014
- Descendant · cites it directly · 0 of its ownK172168 WillCephHdx Will Corp. · 2018
Most influential descendants
Showing 1 of 1 · See all- K172168WillCephHdx Will Corp. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −4 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −3 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −2 | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0 | Practiceworks, Inc. | 2005 | — |
| −1 | K122427 | CS Orthodontic Imaging Software CS Oms Imaging Software | Carestream Dental, LLC | 2012 | — |
| 0 (this device) | K131348 | Ortomed | Infomed Servicios Informaticos S.L. | 2014 | — |
| +1 | K172168 | WillCeph | Hdx Will Corp. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K110430 | Dolphin ImagingSummary page 4…ystem (21 CFR 892.2050) PRODUCT CODE: LLZ REGULATION DESCRIPTION: Picture archiving and communications system PREDICATE DEVICE(S): Dolphin Imaging (K110430) CS Orthodontic Imaging and CS OMS Imaging Software (K122427) DEVICE DESCRIPTION: Ortomed is an… | 2011 |
| * | K122427 | CS Orthodontic Imaging Software CS Oms Imaging SoftwareSummary page 4…and communications system PREDICATE DEVICE(S): Dolphin Imaging (K110430) CS Orthodontic Imaging and CS OMS Imaging Software (K122427) DEVICE DESCRIPTION: Ortomed is an imaging software designed for use by specialized dental practices for capturing, storing and… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172168 | WillCeph | 2018 | 0 |
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 21 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K172168 (Hdx Will Corp., 2018) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K110430.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
ORTOMED is intended for use by specialized dental practices for capturing, storing and presenting patient images and
radiographs and to aid in cephalometric analysis, orthodontic and orthognathic surgery treatment planning and
communication as well as case follow-up. Results produced by the software tools are to be interpreted by trained and
licensed dental practitioners.
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/K131348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131348: Ortomed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131348
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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