# K210931: Libby IAAA v1.0

- Pathway: 510(k) (Traditional)
- Applicant: Dyad Medical, Inc.
- Decided: Dec 17, 2021 after 263 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K941322 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123970: Caas Intravascular, Pie Medical Imaging BV (2013) Summary page 4.

## Indications for use
Libby IAAA is intended to review and analyze Intravascular optical coherence tomography (OCT) images in raw OCT file format. IAAA enables quantification of artery and/or stent dimensions. The software is intended to be used by or under supervision of a Cardiologist.

Source page: https://510kreport.com/device/K210931
Methodology: https://510kreport.com/methodology