# K161920: Comfort Cover

- Pathway: 510(k) (Traditional)
- Applicant: Precision Dynamics Corporation
- Decided: Jul 15, 2016 after 2 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003795 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073262: BELLA, Beekley Corp. (2008) Summary page 4.

## Indications for use
The indications for use of the product is to remove the cold from the bucky by placing this sheet between patient’s breast and the image receptor plate allowing the patient to feel more comfortable and less cold without interfering with image quality.

Source page: https://510kreport.com/device/K161920
Methodology: https://510kreport.com/methodology