# K920879: Brainscan Radiosurgery Module

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab
- Decided: Dec 29, 1992 after 307 days
- Product code: IYE (Accelerator, Linear, Medical)
- 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
No predicates in its family tree.
65 later devices descend from it; 1 cites it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K994413: Brainscan (2000), 64 descendants of its own
- K053584: Iplan RT Dose (2006), 60 descendants of its own
- K032511: Intuition Image (2004), 35 descendants of its own
- K052220: Iplan RT Fibertracking (2005), 34 descendants of its own
- K080886: Iplan RT Image (2008), 33 descendants of its own

## Recalls of this device
- Aug 12, 2009 · Not classified · Z-2251-2009: Failure to conduct important safety checks when using the BrainLab radiotherapy treatment planning software in combination with BrainLab conical collimators could result in unintended radiation outsid

Source page: https://510kreport.com/device/K920879
Methodology: https://510kreport.com/methodology