Cleared Traditional

K163643 - SIRIO H3

K163643 is an FDA 510(k) clearance for SIRIO H3, manufactured by Masmec Spa. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K163643 · Masmec Spa · Radiology device
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Nov 2017
Decision
328d
Days
Class 2
Risk

K163643 is an FDA 510(k) clearance for the SIRIO H3. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Masmec Spa (Modugno (Ba), IT). The FDA issued a Cleared decision on November 16, 2017 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K163643

510(k) Number K163643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2016
Decision Date November 16, 2017
Days to Decision 328 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 107d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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.

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All 646
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