# K110856: RALCO

- Pathway: 510(k) (Traditional)
- Applicant: Ralco S.R.L.
- Decided: Aug 10, 2011 after 135 days
- Product code: IZX (Collimator, Manual, Radiographic)
- Device class: 2
- Regulation: 21 CFR 892.1610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K946320 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030487: R 72, Ralco S.R.L. (2003) Summary page 1.

## Indications for use
RI 04/A, R108 and R108 F Manual X-Ray Collimators are intended for use in diagnostic radiographiclfluorascopic applications.

Source page: https://510kreport.com/device/K110856
Methodology: https://510kreport.com/methodology