Cleared Special

SMART FINDER

K203509 · Ims Giotto S.P.A. · Radiology
Jul 2021
Decision
226d
Days
Class 2
Risk

About This 510(k) Submission

K203509 is an FDA 510(k) clearance for the SMART FINDER, a System, X-ray, Mammographic (Class II — Special Controls, product code IZH), submitted by Ims Giotto S.P.A. (Sasso Marconi, IT). The FDA issued a Cleared decision on July 14, 2021, 226 days after receiving the submission on November 30, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number K203509 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2020
Decision Date July 14, 2021
Days to Decision 226 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IZH — System, X-ray, Mammographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1710