510(k) · Cleared
ClearedPlanmeca Viso
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Planmeca Oy · OAS X-Ray, Tomography, Computed, Dental
Cleared on Dec 28, 2023 as substantially equivalent to K181576 (Planmeca Oy, 2018) and 2 other predicates after a 266-day review. Its family tree reaches back 14 generations to 1980. 3 later devices descend from it.
- Decided
- Dec 28, 2023
- Review
- 266 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K801623 (1980). 139 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 10 generations between
- 3 generations backK162529 DigiX FDXAllengers Medical Systems Limited · 2017
- 2 generations backK192541 DigiX FDXAllengers Medical Systems Limited · 2019
- 1 generation backK223060 DigiX FDXAllengers Medical Systems Limited · 2022
- This deviceK230985 Planmeca VisoPlanmeca Oy · 2023
- Descendant · cites it directly · 1 of its ownK251842 Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK263033 Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1…Fussen Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK261748 Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 13 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 12 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 11 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 10 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 9 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 8 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 7 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 6 generations backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 5 generations backK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- 4 generations backK142049 Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014
- 3 generations backK162529 DigiX FDXAllengers Medical Systems Limited · 2017
- 2 generations backK192541 DigiX FDXAllengers Medical Systems Limited · 2019
- 1 generation backK223060 DigiX FDXAllengers Medical Systems Limited · 2022
- This deviceK230985 Planmeca VisoPlanmeca Oy · 2023
Most influential descendants
Showing 3 of 3 · See all- K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd. · 2025 · cites it directly1descendant
- K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −13 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −12 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −11 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −10 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −9 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −8 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −7 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| −6 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| −5 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| −4 | K142049 | Multix Fusion VA30 & VA40 | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −3 | K162529 | DigiX FDX | Allengers Medical Systems Limited | 2017 | — |
| −2 | K192541 | DigiX FDX | Allengers Medical Systems Limited | 2019 | — |
| −1 | K223060 | DigiX FDX | Allengers Medical Systems Limited | 2022 | — |
| 0 (this device) | K230985 | Planmeca Viso | Planmeca Oy | 2023 | — |
| +1 | K251842 | Dental Computed Tomography X-ray System | Fussen Technology Co., Ltd. | 2025 | — |
| +2 | K263033 | Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3)… | Fussen Technology Co., Ltd. | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K181576 | Planmeca VisoSummary page 4…II Product Code: OAS III. PREDICATE DEVICE Primary predicate device, #1, Planmeca Viso, Computed Tomography System 510(k): K181576 Regulation number: 892.1750 Regulatory Class: II Product Code: OAS Predicate device #2, HDX DENTRIα,… | 2018 |
| * | K160140 | DENTRIa seriesSummary page 4…Regulation number: 892.1750 Regulatory Class: II Product Code: OAS Predicate device #2, HDX DENTRIα, Computed Tomography System 510(k): K160140 Regulation number: 892.1750 Regulatory Class: II Product Code: OAS Predicate device #3, DigiX FDX, S… | 2016 |
| * | K223060 | DigiX FDXSummary page 4…40 Regulation number: 892.1750 Regulatory Class: II Product Code: OAS Predicate device #3, DigiX FDX, Stationary X-ray system 510(k): K223060 Regulation number: 892.1680 Regulatory Class: II Product Code: KPR Predicate device #2… | 2022 |
What descends from it? (3)
2 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 43 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 32 of the 139 ancestors have a recall of any class.
- Of its descendants, K251842 (Fussen Technology Co., Ltd., 2025) has gone furthest, with 1 descendant 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. 2023, 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?
Planmeca Viso is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital X-ray images as well as three-dimensional (3D) optical images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
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/K230985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230985: Planmeca Viso.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230985
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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