Cleared Traditional

Pristina Serena 3D

K182951 · Ge Healthcare · Radiology
Jan 2019
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K182951 is an FDA 510(k) clearance for the Pristina Serena 3D, a Full Field Digital, System, X-ray, Mammographic (Class II — Special Controls, product code MUE), submitted by Ge Healthcare (Buc, FR). The FDA issued a Cleared decision on January 18, 2019, 87 days after receiving the submission on October 23, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1715.

Submission Details

510(k) Number K182951 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 2018
Decision Date January 18, 2019
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUE — Full Field Digital, System, X-ray, Mammographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1715