Cleared Traditional

K213081 - CLISIS SYSTEMS

K213081 is an FDA 510(k) clearance for CLISIS SYSTEMS, manufactured by General Medical Merate S.P.A. The device is a Class 2 Radiology device with product code IZF cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K213081 · General Medical Merate S.P.A · Radiology device
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Oct 2021
Decision
33d
Days
Class 2
Risk

K213081 is an FDA 510(k) clearance for the CLISIS SYSTEMS, Discovery RF180. Classified as System, X-ray, Tomographic (product code IZF), Class II - Special Controls.

Submitted by General Medical Merate S.P.A (Seriate, IT). The FDA issued a Cleared decision on October 26, 2021 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1740 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all General Medical Merate S.P.A devices

FDA 510(k) Submission Details - K213081

510(k) Number K213081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2021
Decision Date October 26, 2021
Days to Decision 33 days
Submission Type Traditional
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
74d faster than avg
Panel avg: 107d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZF Device Classification - Class 2, Special Controls

Product Code IZF System, X-ray, Tomographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1740
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.

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