510(k) · Cleared
ClearedPlanmeca ProMax 3D Max, Planmeca Maximity
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 May 20, 2016 as substantially equivalent to K093590 (Planmeca Oy, 2010) and 1 other predicate after an 86-day review. Its family tree reaches back 5 generations to 1997. 7 later devices descend from it.
- Decided
- May 20, 2016
- Review
- 86 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K973598 (1997). 8 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 4 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 3 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 2 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 1 generation backK093590 Planmeca Promax 3D MaxPlanmeca Oy · 2010
- This deviceK160506 Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy · 2016
- Descendant · cites it directly · 4 of its ownK181576 Planmeca VisoPlanmeca Oy · 2018
- Descendant · 2 generations on · 3 of its ownK230985 Planmeca VisoPlanmeca Oy · 2023
- Descendant · 3 generations on · 1 of its ownK251842 Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK181136 CS 9600Trophy · 2018 · Recalled
- Descendant · 4 generations on · 0 of its ownK263033 Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1…Fussen Technology Co., Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K181576Planmeca VisoPlanmeca Oy · 2018 · cites it directly4descendants
- K230985Planmeca VisoPlanmeca Oy · 2023 · 2 generations on3descendants
- K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd. · 2025 · 3 generations on1descendant
- K181136CS 9600Trophy · 2018 · cites it directly1descendant
- K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −4 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −3 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −2 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −1 | K093590 | Planmeca Promax 3D Max | Planmeca Oy | 2010 | — |
| 0 (this device) | K160506 | Planmeca ProMax 3D Max, Planmeca Maximity | Planmeca Oy | 2016 | — |
| +1 | K181576 | Planmeca Viso | Planmeca Oy | 2018 | — |
| +2 | K230985 | Planmeca Viso | Planmeca Oy | 2023 | — |
| +3 | K251842 | Dental Computed Tomography X-ray System | Fussen Technology Co., Ltd. | 2025 | — |
| +1 | K181136 | CS 9600 | Trophy | 2018 | 1 |
| +4 | K263033 | Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3)… | Fussen Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K093590 | Planmeca Promax 3D MaxSummary page 5…this product modification to be similar in design, composition and function to the following devices introduced into commercial distribution after May 28, 1976: # K093590 Planmeca ProMax 3D Max # K103659 Carestream CS 9300 SUBSTANTIAL EQUIVALENCE The product is principally just th… | 2010 |
| * | K103659 | CS 9300, CS 9300CSummary page 5…sign, composition and function to the following devices introduced into commercial distribution after May 28, 1976: # K093590 Planmeca ProMax 3D Max # K103659 Carestream CS 9300 SUBSTANTIAL EQUIVALENCE The product is principally just the same as in the previous 510(k) #K093590. Th… | 2011 |
What descends from it? (7)
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 19 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K181576 (Planmeca Oy, 2018) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K093590.
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. 2016, 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 Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital X-ray 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/K160506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160506: Planmeca ProMax 3D Max, Planmeca Maximity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160506
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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