# K991237: Xplan-2 with Head and Neck Localizer, Model HNL

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Aug 30, 1999 after 140 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934523 (1995). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972905: XPLAN-1, Radionics Software Applications, Inc. (1997) Summary page 1.
- K981055: Xknife-4, Radionics, Inc. (1998) Summary page 1.
- K934523: Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet (DH-1), Radionics, Inc. (1995) Summary page 2.
- K962155: Gill-Thomas-Cosman (GTC) Dental Tray, Radionics Software Applications, Inc. (1996) Summary page 2.

## Most influential descendants
- 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

## Recalls of this device
- May 25, 2004 · Not classified · Z-1020-04: Software may provide inaccurate coordinates and cause mistreatment

## Indications for use
XPlan-2 is a stereotactic LINAC-based radiation treatment planning system. XPlan-2 localizes lesions to be treated using CT scans, MR scans, and digitized angiographic film. XPlan-2 provides a stereotactic planning system for treatment of tumors at sites such as cranial, base of skull, head and neck. The conformal stereotactic radiation therapy treatments are delivered over multiple fractions.

Source page: https://510kreport.com/device/K991237
Methodology: https://510kreport.com/methodology