Cleared Traditional

BreView

K233714 · GE Medical Systems SCS · Radiology
Jan 2024
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K233714 is an FDA 510(k) clearance for the BreView, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on January 25, 2024, 66 days after receiving the submission on November 20, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K233714 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2023
Decision Date January 25, 2024
Days to Decision 66 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050