SMART FINDER— 510(k) K203509

Substantially Equivalent

Ims Giotto S.P.A.

FDA 510(k) clearance K203509 for SMART FINDER, Substantially Equivalent on 2021-07-14. Applicant: Ims Giotto S.P.A.. Device class: 2.

Clearance details

Applicant: Ims Giotto S.P.A.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2020-11-30
Decision date: 2021-07-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Sasso Marconi, IT

Download summary PDF View on FDA.gov ↗

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More clearances from Ims Giotto S.P.A.

K200424 — Giotto Class (Models - 3000X-YY and 4000X-YY)2020-06-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.