Cleared Traditional

K213579 - Stellaris 2D

K213579 is an FDA 510(k) clearance for Stellaris 2D, manufactured by Fona S.R.L. The device is a Class 2 Radiology device with product code OAS cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K213579 · Fona S.R.L · Radiology device
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Mar 2022
Decision
112d
Days
Class 2
Risk

K213579 is an FDA 510(k) clearance for the Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Fona S.R.L (Assago, IT). The FDA issued a Cleared decision on March 2, 2022 after a review of 112 days - within the typical 510(k) review window.

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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fona S.R.L devices

FDA 510(k) Submission Details - K213579

510(k) Number K213579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2021
Decision Date March 02, 2022
Days to Decision 112 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
5d slower than avg
Panel avg: 107d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAS Device Classification - Class 2, Special Controls

Product Code OAS X-ray, Tomography, Computed, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
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 Peers - OAS X-ray, Tomography, Computed, Dental

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