# K973915: Inflatable Positioning Cushions

- Pathway: 510(k) (Traditional)
- Applicant: Kci New Technologies, Inc.
- Decided: Nov 10, 1997 after 27 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.
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 its predicate without a number.
- (no number) General Purpose T-Foam Pads: named in the summary without a submission number
- (no number) Scintimammography Prone Breast Cushion: named in the summary without a submission number
- (no number) Scintimammography Table Overlay: named in the summary without a submission number
- (no number) Scinti Mammography Positioning Pads: named in the summary without a submission number

## Indications for use
The Inflatable Positioning Cushion device is intended to be used on nuclear imaging tables for Scintimammography procedures. The Inflatable Positioning Cushion allows for comfortable, anatomically correct, prone positioning of the patient during Scintimammography.

Source page: https://510kreport.com/device/K973915
Methodology: https://510kreport.com/methodology