Cleared Traditional

Pristina Serena Bright

K193334 · Ge Healthcare · Radiology

May 2020

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K193334 is an FDA 510(k) clearance for the Pristina Serena Bright, 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 May 15, 2020, 165 days after receiving the submission on December 2, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1715.

Submission Details

510(k) Number	K193334 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 2019
Decision Date	May 15, 2020
Days to Decision	165 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF