# K972905: XPLAN-1

- Pathway: 510(k) (Traditional)
- Applicant: Radionics Software Applications, Inc.
- Decided: Oct 28, 1997 after 83 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
No predicates in its family tree.
4 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) RSA XKnife-3 System: named in the summary without a submission number
- (no number) CMS Focus System: named in the summary without a submission number

## Most influential descendants
- K991237: Xplan-2 with Head and Neck Localizer, Model HNL (1999), 2 descendants of its own
- K081935: Stereotactic Head and Neck Localizer, Model 50-100 (2008), 1 descendant of its own
- K103616: Pinpoint Stereotactic Head and Neck Localizer (2011), 0 descendants of its own
- K981597: Radionics Slice Editor Imaging Software Utility (1998), 0 descendants of its own

## Indications for use
XPlan-1 is a stereotactic LINAC-based radiation treatment planning system. XPlan-1 localizes lesions to be treated using CT scans, MR scans and digitized angiographic film. XPlan-1 provides a stereotactic planning system, for treatment of tumors < 7 cm in diameter at sites such as cranial, base of skull and head. The conformal stereotactic radiation therapy treatments are delivered over multiple fractions.

Source page: https://510kreport.com/device/K972905
Methodology: https://510kreport.com/methodology