# K013861: Modification to Leksell Surgiplan with Atlaspace

- Pathway: 510(k) (Special)
- Applicant: Elekta Instrument AB
- Decided: Dec 6, 2001 after 15 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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 K894263 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943468: Leksell Surgiplan, Elekta Instruments, Inc. (1995) Summary page 1.
- K980584: Atlasplan, Radionics, Inc. (1998) Summary page 1.

## Indications for use
The Leksell® SurgiPlan with AtlasSpace™ is intended for use in planning invasive intra-cranial stereotactic surgical procedures.

Source page: https://510kreport.com/device/K013861
Methodology: https://510kreport.com/methodology