# K994413: Brainscan

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jul 13, 2000 after 197 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: 1 generation back to K920879 (1992). 2 ancestors in all.
64 later devices descend from it; 3 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920879: Brainscan Radiosurgery Module, Brainlab (1992) Summary page 1.
- K971367: Brainscan Conformal RT Module, Brainlab AG (1997) Summary page 1.

## Most influential descendants
- 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
- K080888: Modeification to Iplan RT Dose (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

## Indications for use
BrainSCAN is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and extracranial lesions,

Source page: https://510kreport.com/device/K994413
Methodology: https://510kreport.com/methodology