# K013291: Altair Model, Dei System (Diffractive Energy Imaging System)

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Diagnostics, Inc.
- Decided: Nov 14, 2001 after 43 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K100150: CERAMICS2IN1, Biodenta Swiss AG (2010). Our OCR of the scanned summary read K100150, which FDA decided on May 25, 2010, after this device was decided (Nov 14, 2001), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1.

## Indications for use
Diagnostic ultrasound imaging of human soft tissues **Small parts imaging Is intended for the breast

Source page: https://510kreport.com/device/K013291
Methodology: https://510kreport.com/methodology