# K782155: General Equipment Cover

- Pathway: 510(k) (Traditional)
- Applicant: Contour Fabricators, Inc.
- Decided: Jan 17, 1979 after 26 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K970185: Sterile Disposable Equipment Magnet Cover (1997), 0 descendants of its own
- K964141: GE Sterile Disposable Equipment Coil Cover (1997), 0 descendants of its own

## Recalls of this device
- Aug 29, 2008 · Not classified · Z-1730-2009: GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have sterile seals that could be compromised during the shelf life of the
- Aug 15, 2008 · Not classified · Z-1706-2009: GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the product
- Aug 15, 2008 · Not classified · Z-1708-2009: GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the product
- Aug 15, 2008 · Not classified · Z-1707-2009: GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the product
- Aug 15, 2008 · Not classified · Z-1709-2009: GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the product

Source page: https://510kreport.com/device/K782155
Methodology: https://510kreport.com/methodology