# K982463: Extracranial Radiotherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Sep 30, 1998 after 77 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 K935300 (1994). 6 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960338: Stereotactic Body Frame, Elekta Instrument AB (1996) Summary page 1.
- K892425: STP Complete Module Set, Leibinger & Fischer, Ltd. (1990) Summary page 1.
- K961120: Marker System for Stereotaxic Navigation, Howmedica Leibinger, Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K370291: Stereotactic Body Frame. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K991336: Bodyloc Whole Body Stereotactic Localizer System for Radiotherapy (1999), 7 descendants of its own
- K100691: Omni V SBRT Positioning System, Model RT-4500 (2010), 6 descendants of its own
- K122888: CDR Systems Precision Patient Positioning System (2013), 5 descendants of its own
- K153026: Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement (2016), 3 descendants of its own
- K210894: Siddharth-II; Impact (2021), 1 descendant of its own

## Indications for use
The Extracranial Radiotherapy System is intended for stereotaxic patient positioning and localization during imaging and treatment of extracranial targets.

Source page: https://510kreport.com/device/K982463
Methodology: https://510kreport.com/methodology