# K250755: DS Core Diagnosis

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona, Inc.
- Decided: Aug 12, 2025 after 153 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K954874 (1996). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132773: Sidexis 4, Sirona Dental Systems GmbH (2013) Summary page 5.

## Indications for use
DS Core Diagnosis is a software product for use in dentistry for viewing and interacting with digital or digitized patient media as well as supporting the diagnosis of digital and digitized patient media. Intended users will be able to view and analyze different media types in one viewer. The Panoramic Curve Proposal feature is intended for patients aged 12 years and older with permanent dentition.

Source page: https://510kreport.com/device/K250755
Methodology: https://510kreport.com/methodology