# K213081: CLISIS SYSTEMS, Discovery RF180

- Pathway: 510(k) (Traditional)
- Applicant: General Medical Merate S.P.A
- Decided: Oct 26, 2021 after 33 days
- Product code: IZF (System, X-Ray, Tomographic)
- Device class: 2
- Regulation: 21 CFR 892.1740
- 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 CLISIS SYSTEMS, Discovery RF180 is indicated for performing general radiography, fluoroscopy and angiography procedures. Applications and techniques: - Gastroenterology - Skeleton - Thorax and lungs - Paediatrics - Urology and gynecology - Emergency/traumatology - Digital angiography - Linear tomography - Auto Image Paste (Stitching) - Tomosynthesis

Source page: https://510kreport.com/device/K213081
Methodology: https://510kreport.com/methodology