Cleared Special

K203509 - SMART FINDER (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

K203509 is an FDA 510(k) clearance for the SMART FINDER. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Ims Giotto S.P.A. (Sasso Marconi, IT). The FDA issued a Cleared decision on July 14, 2021 after a review of 226 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ims Giotto S.P.A. devices

Submission Details

510(k) Number K203509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 107d · This submission: 226d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

THEMA S.r.l.
Marisa Testa

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.