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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Consultant

Regulatory Strategies, Inc.
Gregory Mathison

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.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 788
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K163643.
Clear Guide SCENERGY
K171677 · Clear Guide Medical · Dec 2017
NeuViz 16 Essence Multi-slice CT Scanner System
K171198 · Neusoft Medical Systems Co., Ltd. · Dec 2017
CereTom Elite
K172539 · Neurologica Corporation, A Subsidiary of Samsung Electronics · Nov 2017
Philips CT Big Bore
K171850 · Philips Medical Systems (Cleveland), Inc. · Nov 2017
Aquilion Prime SP, TSX-303B/1, v8.4
K172188 · Toshiba Medical Systems Coroporation · Oct 2017
NeuViz Prime Multi-slice CT Scanner System
K171201 · Neusoft Medical Systems Co., Ltd. · Sep 2017
K163643 · SIRIO H3
Download PDF FDA Summary Masmec Spa