# K113449: Fusion Flat Panel

- Pathway: 510(k) (Traditional)
- Applicant: Icrco, Inc.
- Decided: Jun 14, 2012 after 206 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The iCRco Fusion Flat Panel DR System is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding. fluoroscopy, angiography and mammogfaphy. Fusion Flat Panel DR allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

Source page: https://510kreport.com/device/K113449
Methodology: https://510kreport.com/methodology