# K062141: Mammopad Radiolucent Cushion

- Pathway: 510(k) (Traditional)
- Applicant: Biolucent, Inc.
- Decided: Sep 13, 2006 after 48 days
- Product code: IYX (Camera, Scintillation (Gamma))
- Device class: 1
- Regulation: 21 CFR 892.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003795 (2001). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003795: Biolucent Mammography Cushion, Biolucent, Inc. (2001) Summary page 1.
- (no number) Scintimammography Pad Set, PineStar Technology: named in the summary without a submission number
- (no number) Scintimammography Pad, Cone Instruments: named in the summary without a submission number

## Most influential descendants
- K073262: BELLA (2008), 1 descendant of its own
- K161920: Comfort Cover (2016), 0 descendants of its own
- K152038: MammoGRIP (2015), 0 descendants of its own

## Indications for use
Provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray or scintillation technology.

Source page: https://510kreport.com/device/K062141
Methodology: https://510kreport.com/methodology