Cleared Traditional

FDR Cross (DR-XD 3000)

K212956 · Fujifilm Corporation · Radiology

Nov 2021

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K212956 is an FDA 510(k) clearance for the FDR Cross (DR-XD 3000), a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Fujifilm Corporation (Ashigara Kami-Gun, JP). The FDA issued a Cleared decision on November 8, 2021, 53 days after receiving the submission on September 16, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K212956 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2021
Decision Date	November 08, 2021
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy