# K073262: BELLA

- Pathway: 510(k) (Traditional)
- Applicant: Beekley Corp.
- Decided: Mar 26, 2008 after 127 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003795 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062141: Mammopad Radiolucent Cushion, Biolucent, Inc. (2006) Summary page 2.

## Most influential descendants
- K161920: Comfort Cover (2016), 0 descendants of its own

## Recalls of this device
- Jul 2, 2012 · Class II · Z-2080-2012: Imaging artifact can occur on mammogram result

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

Source page: https://510kreport.com/device/K073262
Methodology: https://510kreport.com/methodology