# K013886: Avera Model Dei System (Diffractive Energy Imaging System)

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Diagnostics, Inc.
- Decided: May 10, 2002 after 168 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
Longest line of descent: 1 generation back to K980423 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001510: OS-2000 Optical Sonography System, Advanced Diagnostics, Inc. (2000) Summary page 1.
- K980423: Sonopsy LA System, Neovision Corp. (1998) Summary page 2.

## Indications for use
Diagnostic ultrasound imaging of human soft tissues Other Indications or Modes: 1 Small organ imaging is intended for the breast 2 Breast biopsy

Source page: https://510kreport.com/device/K013886
Methodology: https://510kreport.com/methodology