# K003434: Allegro TB, Allegro N

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Nov 16, 2000 after 10 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
69 later devices descend from it; 2 cite it directly.
0 of 70 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
- K033782: Allegro Imaging System (2003), 67 descendants of its own
- K041955: Gemini Pet/CT Imaging System (2004), 65 descendants of its own
- K062650: EP Navigator Software (2006), 49 descendants of its own
- K101311: EP Navigator R3 (2010), 41 descendants of its own
- K111245: Heartnavigator Release 1 (2011), 39 descendants of its own

Source page: https://510kreport.com/device/K003434
Methodology: https://510kreport.com/methodology