510(k) · Cleared
ClearedOP300
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 Mar 26, 2014 as substantially equivalent to K122018 (Palodex Group OY, 2012) after a 128-day review. Its family tree reaches back 7 generations to 1997. 7 later devices descend from it.
- Decided
- Mar 26, 2014
- Review
- 128 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K973598 (1997). 15 ancestors in all, the oldest K930338 (1993). 7 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 5 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 4 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 3 generations backK073350 Scanora 3DSoredex Palodex Group OY · 2007
- 2 generations backK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- 1 generation backK122018 OP300Palodex Group OY · 2012
- This deviceK133544 OP300Palodex Group OY · 2014
- Descendant · cites it directly · 2 of its ownK180947 Orthopantomograph OP 3DPalodex Group OY · 2018 · Recalled
- Descendant · cites it directly · 2 of its ownK163423 Orthopantomograph OP300Palodex Group OY · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK230505 Orthopantomograph™ OP 3D LXPalodex Group OY · 2023
- Descendant · cites it directly · 1 of its ownK171012 Veraview X800J. Morita USA, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK241249 Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX…Palodex Group OY · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K180947Orthopantomograph OP 3DPalodex Group OY · 2018 · cites it directly2descendants
- K163423Orthopantomograph OP300Palodex Group OY · 2017 · cites it directly2descendants
- K230505Orthopantomograph™ OP 3D LXPalodex Group OY · 2023 · 2 generations on1descendant
- K171012Veraview X800J. Morita USA, Inc. · 2017 · cites it directly1descendant
- K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)Palodex Group OY · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −6 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −5 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −4 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −3 | K073350 | Scanora 3D | Soredex Palodex Group OY | 2007 | — |
| −2 | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| −1 | K122018 | OP300 | Palodex Group OY | 2012 | — |
| 0 (this device) | K133544 | OP300 | Palodex Group OY | 2014 | — |
| +1 | K180947 | Orthopantomograph OP 3D | Palodex Group OY | 2018 | 1 |
| +1 | K163423 | Orthopantomograph OP300 | Palodex Group OY | 2017 | 1 |
| +2 | K230505 | Orthopantomograph™ OP 3D LX | Palodex Group OY | 2023 | — |
| +1 | K171012 | Veraview X800 | J. Morita USA, Inc. | 2017 | — |
| +3 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K122018 | OP300Summary page 2…eristics: 0P300 is substantially equivalent in design, composition and function to the current 0P300 unit. Concept OP300 (K1 22018) 0P300 (Modified) 1. Indications for use The 0P300 dental panoramic,… | 2012 |
What descends from it? (7)
4 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 17 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K180947 (Palodex Group OY, 2018) has gone furthest, with 2 descendants of its own.
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. 2014, 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 OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133544 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133544: OP300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133544
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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