# K994355: Radiocameras System Head/Neck Application

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Navigation Technologies, Inc.
- Decided: Mar 22, 2000 after 90 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 no predicate by number.

## Most influential descendants
- K071360: Optical Guidance Platform (2007), 2 descendants of its own
- K142560: Varian Head Frame (2014), 1 descendant of its own
- K180586: Varian Head Frame (2018), 0 descendants of its own
- K042875: Navigator (2005), 0 descendants of its own

## Indications for use
The RadioCameras™ Biteblock System Head/Neck Application is indicated for use with a photon linear accelerator to perform Stereotactic Radiosurgery or Radiotherapy on head and neck theraputic targets that lie outside the cranium. It provides precise positioning of the treatment target at the Linear Accelerator's isocenter.

Source page: https://510kreport.com/device/K994355
Methodology: https://510kreport.com/methodology