# K971367: Brainscan Conformal RT Module

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Oct 27, 1997 after 196 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.
95 later devices descend from it; 2 cite it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K994413: Brainscan (2000), 64 descendants of its own
- K053584: Iplan RT Dose (2006), 60 descendants of its own
- K032762: Xio Radiation Treatment Planning System (2003), 52 descendants of its own
- K032511: Intuition Image (2004), 35 descendants of its own
- K092132: Xio RTP System (2009), 34 descendants of its own

## Indications for use
Computer aided planning of static and dynamic conformal radiation therapy treatments. The BrainSCAN Conformal RT Module is intended to plan radiation therapy treatments of lesions using conformal block collimators that are shaped (i.e. contour molded) to the outline of the lesion in beam’s eye view or using a multileaf collimator. Using shaped collimators helps to deliver radiation exactly to the target volume while sparing surrounding healthy tissue and critical structures from accessing radiation.

Source page: https://510kreport.com/device/K971367
Methodology: https://510kreport.com/methodology