# K150785: syngo.CT Dental

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 18, 2015 after 54 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913996 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913996: Computerized Tomography X-Ray System Option, Siemens Medical Solutions USA, Inc. (1991) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K150785
Methodology: https://510kreport.com/methodology