510(k) · Cleared
ClearedAudaxCeph Cephalogram Analysis Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Audax D.O.O. · QIH Automated Radiological Image Processing Software
Cleared on May 30, 2025 as substantially equivalent to K231396 (Orca Dental AI, Ltd., 2024) after a 246-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- May 30, 2025
- Review
- 246 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K930527 (1993). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK930527 Dental LinkEscan, Inc. · 1993
- 6 generations between
- 3 generations backK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- 2 generations backK220903 WebCephAssemblecircle Corp. · 2022
- 1 generation backK231396 CEPHX- Cephalometric Analysis SoftwareOrca Dental AI, Ltd. · 2024
- This deviceK243005 AudaxCeph Cephalogram Analysis SoftwareAudax D.O.O. · 2025
Show all 10 generations
- Root · 10 generations backK930527 Dental LinkEscan, Inc. · 1993
- 9 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 8 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 7 generations backK043104 Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005
- 6 generations backK122427 CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC · 2012
- 5 generations backK131570 OrthovisionEwoosoft Co., Ltd. · 2013
- 4 generations backK173094 OrthoVisionEwoosoft Co., Ltd. · 2017
- 3 generations backK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- 2 generations backK220903 WebCephAssemblecircle Corp. · 2022
- 1 generation backK231396 CEPHX- Cephalometric Analysis SoftwareOrca Dental AI, Ltd. · 2024
- This deviceK243005 AudaxCeph Cephalogram Analysis SoftwareAudax D.O.O. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −9 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −8 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −7 | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0 | Practiceworks, Inc. | 2005 | — |
| −6 | K122427 | CS Orthodontic Imaging Software CS Oms Imaging Software | Carestream Dental, LLC | 2012 | — |
| −5 | K131570 | Orthovision | Ewoosoft Co., Ltd. | 2013 | — |
| −4 | K173094 | OrthoVision | Ewoosoft Co., Ltd. | 2017 | — |
| −3 | K192888 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| −2 | K220903 | WebCeph | Assemblecircle Corp. | 2022 | — |
| −1 | K231396 | CEPHX- Cephalometric Analysis Software | Orca Dental AI, Ltd. | 2024 | — |
| 0 (this device) | K243005 | AudaxCeph Cephalogram Analysis Software | Audax D.O.O. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K231396 | CEPHX- Cephalometric Analysis SoftwareSummary page 5…QIH DEVICE CLASS: II PREDICATE DEVICE: The predicate device chosen for this submission is CephX Cephalometric Analysis Software (K231396) cleared on January 31, 2024, legally marketed by Orca Dental AI, Ltd. No reference devices were used in this submission. To id… | 2024 |
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 32 years and passes through 9 companies; a new generation was cleared every 2.8 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
AudaxCeph Cephalogram Analysis Software is designed for use by specialized dental practices for storing and presenting patient images and assisting in treatment planning. Results produced by the software's treatment planning tools are dependent on the interpretation of trained and licensed practitioners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243005: AudaxCeph Cephalogram Analysis Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243005
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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