# K222975: Advantis Platform

- Pathway: 510(k) (Traditional)
- Applicant: Advantis Medical Imaging Single Member P.C.
- Decided: Mar 1, 2023 after 154 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: 15 generations back to K971684 (1997). 199 ancestors in all.
No later device cites it as a predicate yet.
5 of 200 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202808: Brainance MD, Advantis Medical Imaging Single Member P.C. (2021) Summary page 4.
- K180336: syngo.MR Applications, Siemens Medical Solutions USA, Inc. (2018) Summary page 4.

## Indications for use
Advantis Platform provides analysis and visualization capabilities of dynamic MRI data of the brain and prostate, presenting the derived properties and parameters in a clinically useful context. Advantis Platform is intended as a general medical image management and processing system. Advantis Platform is intended to be used by trained healthcare professionals and provides information that, in a clinical setting, may assist in the interpretation of brain and prostate MR studies of adult population. Diagnosis should not be made solely based on the analysis performed using Advantis Platform.

Source page: https://510kreport.com/device/K222975
Methodology: https://510kreport.com/methodology