510(k) · Cleared
ClearedOrthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palodex Group OY · OAS X-Ray, Tomography, Computed, Dental
Cleared on Sep 12, 2024 as substantially equivalent to K230505 (Palodex Group OY, 2023) after a 132-day review. Its family tree reaches back 10 generations to 1997.
- Decided
- Sep 12, 2024
- Review
- 132 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K973598 (1997). 21 ancestors in all, the oldest K930338 (1993). No later device cites it as a predicate yet.
- Root · 10 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations between
- 3 generations backK133544 OP300Palodex Group OY · 2014
- 2 generations backK163423 Orthopantomograph OP300Palodex Group OY · 2017 · Recalled
- 1 generation backK230505 Orthopantomograph™ OP 3D LXPalodex Group OY · 2023
- This deviceK241249 Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX…Palodex Group OY · 2024
Show all 10 generations
- Root · 10 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 9 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 8 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 7 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 6 generations backK073350 Scanora 3DSoredex Palodex Group OY · 2007
- 5 generations backK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- 4 generations backK122018 OP300Palodex Group OY · 2012
- 3 generations backK133544 OP300Palodex Group OY · 2014
- 2 generations backK163423 Orthopantomograph OP300Palodex Group OY · 2017 · Recalled
- 1 generation backK230505 Orthopantomograph™ OP 3D LXPalodex Group OY · 2023
- This deviceK241249 Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX…Palodex Group OY · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −9 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −8 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −7 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −6 | K073350 | Scanora 3D | Soredex Palodex Group OY | 2007 | — |
| −5 | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| −4 | K122018 | OP300 | Palodex Group OY | 2012 | — |
| −3 | K133544 | OP300 | Palodex Group OY | 2014 | — |
| −2 | K163423 | Orthopantomograph OP300 | Palodex Group OY | 2017 | 1 |
| −1 | K230505 | Orthopantomograph™ OP 3D LX | Palodex Group OY | 2023 | — |
| 0 (this device) | K241249 | Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) | Palodex Group OY | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 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 OAS? 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 OAS device
- #1 K213226 RCT700score 18.0 · 13 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 |
|---|---|---|---|
| * | K230505 | Orthopantomograph™ OP 3D LXSummary page 6…Page 6 === This section provides the substantial equivalence rationale for ORTHOPANTOMOGRAPH™ OP 3D LX, and the Primary Predicate Device, ORTHOPANTOMOGRAPH"' OP 3D LX (1<230505) with regards to Indications for Use, Technology, and Performance Testing. As described in this section, the differences between… | 2023 |
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 27 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 21 ancestors have a recall of any class.
How does its category compare?
All OAS devicesOAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OAS
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAS
144in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAS
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAS
1in 2025
MAUDE reports naming product code OAS, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 6 | 168 | 0 | 0 |
| 2012 | 7 | 110 | 0 | 0 |
| 2013 | 10 | 155 | 0 | 0 |
| 2014 | 5 | 170 | 0 | 0 |
| 2015 | 5 | 164 | 1 | 0 |
| 2016 | 12 | 154 | 0 | 0 |
| 2017 | 4 | 209 | 0 | 0 |
| 2018 | 11 | 57 | 0 | 0 |
| 2019 | 7 | 55 | 0 | 1 |
| 2020 | 9 | 113 | 0 | 0 |
| 2021 | 11 | 92 | 0 | 0 |
| 2022 | 6 | 105 | 0 | 1 |
| 2023 | 12 | 77 | 0 | 1 |
| 2024 | 4 | 129 | 0 | 2 |
| 2025 | 9 | 144 | 3 | 1 |
| 2026 | 9 | 77 | 0 | — |
What is it indicated for?
ORTHOPANTOMOGRAPH™ OP 3D LX is an X-ray device that is intended to be used for imaging of adult and pediatric patients. The device can be configured to take panoramic, cephalometric or 3D images of cranio-maxillofacial complex including the ear, nose and throat (ENT) and airway regions, and cervical spine. The device can be configured to take carpus images.
The device is operated and used by qualified healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241249: Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241249
Report an extraction error
Are you the manufacturer?
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