510(k) · Cleared
ClearedDental Cone-beam Computed Tomography (mDX-15P Series)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hefei Meyer Optoelectronic Technology, Inc. · OAS X-Ray, Tomography, Computed, Dental
Cleared on Jul 23, 2026 as substantially equivalent to K230985 (Planmeca Oy, 2023) after a 56-day review. Its family tree reaches back 15 generations to 1980.
- Decided
- Jul 23, 2026
- Review
- 56 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K801623 (1980). 140 ancestors in all. No later device cites it as a predicate yet.
- Root · 15 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 11 generations between
- 3 generations backK192541 DigiX FDXAllengers Medical Systems Limited · 2019
- 2 generations backK223060 DigiX FDXAllengers Medical Systems Limited · 2022
- 1 generation backK230985 Planmeca VisoPlanmeca Oy · 2023
- This deviceK261748 Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc. · 2026
Show all 15 generations
- Root · 15 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 14 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 13 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 12 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 11 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 10 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 9 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 8 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 7 generations backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 6 generations backK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- 5 generations backK142049 Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014
- 4 generations backK162529 DigiX FDXAllengers Medical Systems Limited · 2017
- 3 generations backK192541 DigiX FDXAllengers Medical Systems Limited · 2019
- 2 generations backK223060 DigiX FDXAllengers Medical Systems Limited · 2022
- 1 generation backK230985 Planmeca VisoPlanmeca Oy · 2023
- This deviceK261748 Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −14 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −13 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −12 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −11 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −10 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −9 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −8 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| −7 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| −6 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| −5 | K142049 | Multix Fusion VA30 & VA40 | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −4 | K162529 | DigiX FDX | Allengers Medical Systems Limited | 2017 | — |
| −3 | K192541 | DigiX FDX | Allengers Medical Systems Limited | 2019 | — |
| −2 | K223060 | DigiX FDX | Allengers Medical Systems Limited | 2022 | — |
| −1 | K230985 | Planmeca Viso | Planmeca Oy | 2023 | — |
| 0 (this device) | K261748 | Dental Cone-beam Computed Tomography (mDX-15P Series) | Hefei Meyer Optoelectronic Technology, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 13 | 0 |
| 1996 | 7 | 0 |
| 1997 | 7 | 0 |
| 1998 | 5 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 9 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 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 |
|---|---|---|---|
| * | K230985 | Planmeca VisoSummary page 5…21 CFR 892.1750 Regulatory Class: Class II Product code: OAS Review Panel: Radiology III. Predicate Devices 510(k) Number: K230985 Trade name: Planmeca Viso Common name: Computed tomography x-ray system. Classification: Class… | 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 46 years and passes through 9 companies; a new generation was cleared every 2.2 years on median.
- 32 of the 140 ancestors have a recall of any class.
- 1 other device also cites its predicate K230985.
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. 2026, 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 equipment is intended to produce two-dimensional (2D) or three-dimensional (3D) images of
the human dental, maxillofacial regions and/or skull as diagnostic support for adult and pediatric
patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261748 · printed Nov 5, 2026
Cite this page
510(k) Report. “K261748: Dental Cone-beam Computed Tomography (mDX-15P Series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K261748
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026