Cleared Traditional

SenoBright HD

K211215 · Ge Healthcare · Radiology
Jun 2021
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K211215 is an FDA 510(k) clearance for the SenoBright HD, 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 June 22, 2021, 60 days after receiving the submission on April 23, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1715.

Submission Details

510(k) Number K211215 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2021
Decision Date June 22, 2021
Days to Decision 60 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