# K021191: Autoalign

- Pathway: 510(k) (Abbreviated)
- Applicant: Cortechs Labs, Inc.
- Decided: Jul 12, 2002 after 88 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: 2 generations back to K941223 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010938: Syngo Multimodality Workstation, Siemens Medical Solutions USA, Inc. (2001)
- K983256: Advantage Windows (AW) Fusion, GE Medical Systems (1998) Summary page 2.

## Indications for use
To be utilized for the registration of brain images for MRI.

Source page: https://510kreport.com/device/K021191
Methodology: https://510kreport.com/methodology