# K012563: Deep Gray

- Pathway: 510(k) (Abbreviated)
- Applicant: Cortechs Labs, Inc.
- Decided: Nov 2, 2001 after 85 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 K913770 (1991). 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)
- K002519: Vitrea 2, Version 2.1, Vital Images, Inc. (2000) Summary page 2.
- K963345: Advantage Windows Tissue Volume Option, GE Medical Systems (1996) Summary page 2.

## Indications for use
Visualization/Processing/Analysis of brain images from MR scanners.

Source page: https://510kreport.com/device/K012563
Methodology: https://510kreport.com/methodology