510(k) · Cleared
Clearedsyngo.CT Dental
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on May 18, 2015 as substantially equivalent to K913996 (Siemens Medical Solutions USA, Inc., 1991) after a 54-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- May 18, 2015
- Review
- 54 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913996 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK913996 Computerized Tomography X-Ray System OptionSiemens Medical Solutions USA, Inc. · 1991
- This deviceK150785 syngo.CT DentalSiemens Medical Solutions USA, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913996 | Computerized Tomography X-Ray System Option | Siemens Medical Solutions USA, Inc. | 1991 | — |
| 0 (this device) | K150785 | syngo.CT Dental | Siemens Medical Solutions USA, Inc. | 2015 | — |
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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K913996 | Computerized Tomography X-Ray System OptionSummary page 5…Traditional 510(k) Submission: syngo.CT Dental 4. Legally Marketed Predicate Device Trade Name: Dental CT Option 510(k) #: K913996 Clearance Date: November 22, 1991 Classification Name: Computed Tomography X-ray System Classi… | 1991 |
| † | K123375 | Syngo.Via | 2012 |
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?
- Its one ancestor has no recall.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
Syngo.CT Dental is post processing image analysis software for CT volume data sets that has been acquired continuously with computed tomography (CT) systems. The software provides the following digital image processing and visualization tools: Basic reading tools: Multiplanar Reconstruction (MPR), Maximum Intensity Projection (MIP), Volume Rendering Technique (VRT), Minimal Intensity Projection (MinIP) Basic geometric measurement tools: distance line…
Read the full statement (222 words)
Syngo.CT Dental is post processing image analysis software for CT volume data sets that has been acquired continuously with computed tomography (CT) systems. The software provides the following digital image processing and visualization tools:
Basic reading tools: Multiplanar Reconstruction (MPR), Maximum Intensity Projection (MIP), Volume Rendering Technique (VRT), Minimal Intensity Projection (MinIP)
Basic geometric measurement tools: distance line, polyline, marker, arrow, angle
Basic HU measurement tools: Pixel lens, ROI Circle, ROI polygonal, ROI freehand, VOI sphere, VOI freehand
Dedicated dental visualization tools: Dental panoramic views (curved MPRs) and dental paraxial views (cross-section MPRs) that are calculated based on a manually defined centerline.
A tool to manually outline the mandibular canal.
A tool that allows paraxial and panoramic result images to be saved as dental range series.
True Size (1:1) printing of panoramic and paraxial images to allow anatomy to be printed in its actual size on the film sheet.
The specific visualization of panoramic and paraxial views of the dental structures facilitates viewing, manual identification, and marking of dental pathologies and anatomy (for example, the position of the mandibular canal that needs to be preserved during dental interventions, such as dental (implant) surgery). Reporting and documentation of results is facilitated by the creation of ranges and snapshots, True Size (1:1) printing on DICOM printers, and by the use of a reporting tool.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150785 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150785: syngo.CT Dental.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150785
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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