# K001510: OS-2000 Optical Sonography System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Diagnostics, Inc.
- Decided: Nov 30, 2000 after 199 days
- Product code: NCS (System, Imaging, Holography, Acoustic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K013886: Avera Model Dei System (Diffractive Energy Imaging System) (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K001510
Methodology: https://510kreport.com/methodology