# K080655: Chrysalis

- Pathway: 510(k) (Traditional)
- Applicant: Meta Imaging Solutions, LLC
- Decided: May 9, 2008 after 63 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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 FDA summary names no predicate by number.

## Indications for use
The device described here is an accessory to imaging devices previously approved. In general, the intended professional application is described as follows: Breast displacement for imaging purposes with the intention of decreasing radiation dose to the breasts and/or improving image quality. The Chrysalis device is reusable and used external to hospital garb; it does not touch the patient's body.

Source page: https://510kreport.com/device/K080655
Methodology: https://510kreport.com/methodology