Cleared Traditional

CLISIS SYSTEMS, Discovery RF180

K213081 · General Medical Merate S.P.A · Radiology
Oct 2021
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K213081 is an FDA 510(k) clearance for the CLISIS SYSTEMS, Discovery RF180, a System, X-ray, Tomographic (Class II — Special Controls, product code IZF), submitted by General Medical Merate S.P.A (Seriate, IT). The FDA issued a Cleared decision on October 26, 2021, 33 days after receiving the submission on September 23, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1740.

Submission Details

510(k) Number K213081 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2021
Decision Date October 26, 2021
Days to Decision 33 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IZF — System, X-ray, Tomographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1740