# K052212: MIGUE

- Pathway: 510(k) (Traditional)
- Applicant: Direx Systems Corp.
- Decided: Mar 10, 2006 after 207 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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 K003285 (2001). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041213: 3DSCOPE, Direx Systems Corp. (2004) Summary page 1.
- K040585: Exactrac 4.0 and Exactrac X-Ray 6D, Brainlab AG (2004) Summary page 1.

## Most influential descendants
- K061713: MAGIS1;MAGIS2 (2006), 0 descendants of its own

## Indications for use
MIGUE is intended to aid in patient target to radiation beam set-up for administration of radiation therapy. It is indicated for all body procedures.

Source page: https://510kreport.com/device/K052212
Methodology: https://510kreport.com/methodology