# K231351: Chondral Quant

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Soultions USA, Inc.
- Decided: Jul 13, 2023 after 65 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: 16 generations back to K971684 (1997). 192 ancestors in all.
No later device cites it as a predicate yet.
5 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182904: syngo.MR Applications, Siemens Medical Solutions USA, Inc. (2019) Summary page 5.

## Indications for use
Chondral Quant is a musculoskeletal post-processing software application that allows assessment of knee cartilage condition based on Magnetic Resonance Imaging (MRI).

Source page: https://510kreport.com/device/K231351
Methodology: https://510kreport.com/methodology