# K150069: Fine Structure Analysis (fineSA)

- Pathway: 510(k) (Traditional)
- Applicant: Acuitas Medical, Ltd.
- Decided: May 22, 2015 after 129 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: 11 generations back to K971684 (1997). 34 ancestors in all.
No later device cites it as a predicate yet.
3 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130749: Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular, Siemens Medical Solutions USA, Inc. (2013) Summary page 4.

## Indications for use
fineSA software is intended for use as a non-invasive device that processes designated MR images using the 2-D pulse sequence incorporated on Siemens Medical 3T MAGNETOM systems running syngo MR software versions B17 and D13. This includes the Aera, Skyra, Avanto and Verio models. fineSA software generates reports that provide information about the structural features in bone. The MR data, in the form of spectra or spectral images, reflect the spacing of structural features at a scale of approximately 500 microns or larger.

Source page: https://510kreport.com/device/K150069
Methodology: https://510kreport.com/methodology