# K972130: Disposable Camera Cover, Enclosed: Disposable Camera Cover, Perforated: Disposable Microscope Cover (Various):X-Ray Covr

- Pathway: 510(k) (Traditional)
- Applicant: Fairmontmedical
- Decided: Oct 9, 1997 after 125 days
- Product code: IZJ (Camera, X-Ray, Fluorographic, Cine Or Spot)
- Device class: 2
- Regulation: 21 CFR 892.1620
- 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 no predicate by number.

## Indications for use
The Disposable X-Ray Cover is a sterile cover or drape for operative X-ray machine utilised during surgical procedures which require a sterile environment. It allows a surgeon to adjust and manoeuvre at will, without compromising the sterile field. The DXC provides a sterile barrier between the patient and the X-ray machine. Contaminants from the operative equipment (the X-ray machine) cannot penetrate through to infect the patient. Patient contaminants (such as blood and bodily fluids) cannot penetrate through to damage the machine. The DXC is disposable and single patient use only, so there is no cross contamination between patients. It is sterilised via gamma radiation. This product is marketed towards surgeons and hospitals concerned with the convenience and protection of covering an operative X-ray machine, so that it will not contaminate the sterile field.

Source page: https://510kreport.com/device/K972130
Methodology: https://510kreport.com/methodology