Cleared Special

K214084 - hyperion X9 pro

K214084 is the FDA 510(k) clearance for hyperion X9 pro by Cefla S.C.. It is a Class 2 Radiology device (product code OAS) cleared through the Special 510(k) pathway after a 24-day FDA review.

K214084 · Cefla S.C. · Radiology device
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Jan 2022
Decision
24d
Days
Class 2
Risk

K214084 is an FDA 510(k) clearance for the hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Cefla S.C. (Imola (Bo), IT). The FDA issued a Cleared decision on January 20, 2022 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cefla S.C. devices

Submission Details

510(k) Number K214084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2021
Decision Date January 20, 2022
Days to Decision 24 days
Submission Type Special
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
83d faster than avg
Panel avg: 107d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

All 89
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