# K003285: Exac Trac 2.0 (Novalis Body Module)

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jul 31, 2001 after 285 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.
58 later devices descend from it; 6 cite it directly.
0 of 59 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
- K040585: Exactrac 4.0 and Exactrac X-Ray 6D (2004), 41 descendants of its own
- K033287: Exactrac Gating (2003), 16 descendants of its own
- K072506: Exactrac 5.5 (2007), 15 descendants of its own
- K072046: Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac Oem (2007), 13 descendants of its own
- K060906: Calypso 4D Localization System (2006), 11 descendants of its own

Source page: https://510kreport.com/device/K003285
Methodology: https://510kreport.com/methodology