# K251030: Sirona Advanced Imaging Suite

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Medical
- Decided: Oct 22, 2025 after 202 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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 K942120 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101342: Osirix MD, Pixmeo Sarl (2010) Summary page 5.

## Indications for use
Sirona Advanced Imaging Suite is a Medical Image Management and Processing System and consists of four PET (Positron Emission Tomography) viewing features which is used for the viewing, registration, fusion, and/or display for diagnosis of medical images from the following modalities: PET and CT. These features are as follows: a. PET-CT overlay/fusion, b. Measurement of Standardized Uptake Value on PET image series and generated PET-CT overlay/fusion, c. Maximum Intensity Reconstruction of PET image series, d. Multiplanar Reconstruction of PET image series and PET-CT overlay/ fusion. Sirona Advanced Imaging Suite is intended to be used with the Sirona PACS (or MIMPS) Viewer. The intended users of the PET Module are trained radiologists, medical professionals, or other healthcare providers within a healthcare organization.

Source page: https://510kreport.com/device/K251030
Methodology: https://510kreport.com/methodology