# K023229: S.O.F.T. Paddle (Special Optimized Full Compression Tray), Model SFT-Pdle

- Pathway: 510(k) (Traditional)
- Applicant: American Mammographics, Inc.
- Decided: Dec 13, 2002 after 77 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mammographic compression devices marketed by GE, Lorad, Planmed, and Instrumentarium: named in the summary without a submission number

## Most influential descendants
- K033202: Advantage Paddle (2003), 0 descendants of its own

## Indications for use
For use In Screening Mammographic Imaging as a Specialty Paddle for Full Breast Cornpressian as an alternative to conventional breast compression paddles.

Source page: https://510kreport.com/device/K023229
Methodology: https://510kreport.com/methodology