Cleared Traditional

K123381 - HYPERION X9 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K123381 · Cefla S.C. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
190d
Days
Class 2
Risk

K123381 is an FDA 510(k) clearance for the HYPERION X9. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Cefla S.C. (Ormond Beach, US). The FDA issued a Cleared decision on May 10, 2013 after a review of 190 days - an extended review cycle.

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 Cefla S.C. devices

Submission Details

510(k) Number K123381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2012
Decision Date May 10, 2013
Days to Decision 190 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 107d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 129
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K123381.
RCT800
K260462 · Ray Co., Ltd. · Apr 2026
myray ProXIma X6
K252353 · Cefla S.C. · Mar 2026
Primevision 3D
K253959 · Dentsply Sirona · Feb 2026
RCT700
K251798 · Ray Co., Ltd. · Nov 2025
Dental Computed Tomography X-ray System
K251842 · Fussen Technology Co., Ltd. · Nov 2025
GT300
K250060 · Genoray Co., Ltd. · Oct 2025