# K002509: Novalis (Shaped Beam Surgery System)

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Nov 3, 2000 after 80 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
No predicates in its family tree.
88 later devices descend from it; 1 cites it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K033343: Trilogy Radiotherapy Delivery System (2003), 87 descendants of its own
- K061140: Trilogy Radiotherapy Delivery System (2006), 86 descendants of its own
- K070094: Trilogy Radiotherapy Delivery System and Trilogy TX Delivery System (2007), 78 descendants of its own
- K072916: Trilogy System with Rapidarc (2007), 77 descendants of its own
- K092871: Trilogy MX (2009), 61 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/K002509
Methodology: https://510kreport.com/methodology