Cleared Traditional

Adora DRFi (04550010)

K242948 · Nrt X-Ray A/S · Radiology

Dec 2024

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K242948 is an FDA 510(k) clearance for the Adora DRFi (04550010), a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Nrt X-Ray A/S (Hasselager, DK). The FDA issued a Cleared decision on December 23, 2024, 89 days after receiving the submission on September 25, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K242948 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2024
Decision Date	December 23, 2024
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF