# K153593: CliniscanSM MRI

- Pathway: 510(k) (Traditional)
- Applicant: Picofemto, LLC
- Decided: Feb 17, 2016 after 63 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
1. CliniscanSM MRI is intended for automatic labeling, visualization and volumetric quantification of segmented brain structures from a set of MRI images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmental brain structures identified on MR images. 2. This software is intended for use on adult patients only (18+ years). 3. CliniscanSM MRI is NOT intended to diagnose, treat, cure or prevent any disease. All results must be reviewed by a qualified healthcare professional prior to any diagnosis.

Source page: https://510kreport.com/device/K153593
Methodology: https://510kreport.com/methodology