510(k) · Cleared
Recalled · Class II · 2021Orthopantomograph OP300
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 Aug 31, 2017 as substantially equivalent to K110839 (Soredex Palodex Group OY, 2011) and 1 other predicate after a 268-day review. Its family tree reaches back 8 generations to 1997. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 31, 2017
- Review
- 268 days
- Class
- Class II
- Product code
- OAS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K973598 (1997). 18 ancestors in all, the oldest K930338 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 7 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 6 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 5 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 4 generations backK073350 Scanora 3DSoredex Palodex Group OY · 2007
- 3 generations backK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- 2 generations backK122018 OP300Palodex Group OY · 2012
- 1 generation backK133544 OP300Palodex Group OY · 2014
- This deviceK163423 Orthopantomograph OP300Palodex Group OY · 2017
- Descendant · cites it directly · 1 of its ownK230505 Orthopantomograph™ OP 3D LXPalodex Group OY · 2023
- Descendant · 2 generations on · 0 of its ownK241249 Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX…Palodex Group OY · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −7 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −6 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −5 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −4 | K073350 | Scanora 3D | Soredex Palodex Group OY | 2007 | — |
| −3 | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| −2 | K122018 | OP300 | Palodex Group OY | 2012 | — |
| −1 | K133544 | OP300 | Palodex Group OY | 2014 | — |
| 0 (this device) | K163423 | Orthopantomograph OP300 | Palodex Group OY | 2017 | — |
| +1 | K230505 | Orthopantomograph™ OP 3D LX | Palodex Group OY | 2023 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K110839 | Scanora 3DSummary page 4…aphy x-ray system CFR Number: 892.1750 Device Class: II Product Code: OAS Predicate Devices: Proprietary Name: Scanora 3D 510(k) Number K110839 Common Name: X-ray, Tomography, Computed, Dental Classification Name: Computed tomography x-ray system CFR Number:… | 2011 |
| * | K133544 | OP300Summary page 4…tomography x-ray system CFR Number: 892.1750 Device Class: II Product Code: OAS Proprietary Name: Orthopantomograph OP300 510(k) Number K133544 Common Name: X-ray, Tomography, Computed, Dental Classification Name: Computed tomography x-ray system CFR Number:… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230505 | Orthopantomograph™ OP 3D LX | 2023 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 28, 2021 | Class II | Z-2413-2024 | Radiation Control for Health and Safety Act | It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatability test even when the test result is not within the set acceptance criteria (repeatability within 4%). |
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 2.6 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K230505 (Palodex Group OY, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K110839.
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. 2017, 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?
The Orthopantomograph OP300 panoramic, cephalometric and cone beam computed tomography x-ray device is intended to image the head and neck areas for diagnostic support. This includes temporomandibular Joints (TMJs) and dentomaxillofacial areas, and with the 13x15 cm field of view (FOV) this additionally includes the ear, nose and throat (ENT) regions. The x-ray device produces conventional 2D x-ray images and x-ray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.
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/K163423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163423: Orthopantomograph OP300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163423
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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