# K980584: Atlasplan

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: May 18, 1998 after 90 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: 1 generation back to K894263 (1989). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894263: Cass System, Medical Instrumentation & Diagnostics Corp.(Midco) (1989) Summary page 1.
- K911750: Computer Assist Stereotactic Surg Syst, Modified, Medical Instrumentation & Diagnostics Corp.(Midco) (1991) Summary page 1.
- K921740: Computer Assisted Stereotactic Surgery -- Modified, Medical Instrumentation & Diagnostics Corp.(Midco) (1993) Summary page 1.

## Most influential descendants
- K013861: Modification to Leksell Surgiplan with Atlaspace (2001), 0 descendants of its own

## Indications for use
AtlasPlan is intended to be used for pre- and intra-operative planning of stereotactic procedures. This software module correlates a patient's anatomy (obtained from CT or MRI scans) with an anatomical atlas of the brain. AtlasPlan may be used alone or in conjunction with neurosurgery, radiotherapy, and radiosurgery planning systems.

Source page: https://510kreport.com/device/K980584
Methodology: https://510kreport.com/methodology