# K201948: AcroDTI Visualizer

- Pathway: 510(k) (Traditional)
- Applicant: Acroviz, Inc.
- Decided: Sep 9, 2020 after 58 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: 14 generations back to K971684 (1997). 200 ancestors in all.
No later device cites it as a predicate yet.
5 of 201 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163294: syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology, Siemens Medical Solutions USA, Inc. (2017) Summary page 5.
- K170580: Carestream Vue PACS, Carestream Health, Inc. (2017) Summary page 5.

## Indications for use
AcroDTI Visualizer is an image processing software that allows the user to calculate and display DTI from diffusion MRI (dMRl) data. This software is intended to be utilized by trained physicians to visually evaluate the DTI index maps.

Source page: https://510kreport.com/device/K201948
Methodology: https://510kreport.com/methodology