Cleared Traditional

K243337 - Dental Cone Beam Computed Tomography System

K243337 is an FDA 510(k) clearance for Dental Cone Beam Computed Tomography System, manufactured by Yofo Medical Technology Co., Ltd.. The device is a Class 2 Radiology device with product code OAS cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K243337 · Yofo Medical Technology Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
174d
Days
Class 2
Risk

K243337 is an FDA 510(k) clearance for the Dental Cone Beam Computed Tomography System. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Yofo Medical Technology Co., Ltd. (Hefei, CN). The FDA issued a Cleared decision on April 17, 2025 after a review of 174 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 Yofo Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K243337

510(k) Number K243337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2024
Decision Date April 17, 2025
Days to Decision 174 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
67d slower than avg
Panel avg: 107d · This submission: 174d
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

All 97
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K243337.
Dental Computed Tomography X-ray System
K251842 · Fussen Technology Co., Ltd. · Nov 2025
GT300
K250060 · Genoray Co., Ltd. · Oct 2025
Dental CBCT X-ray System
K251642 · Yian Medical Technology (Haining) Co., Ltd. · Jun 2025
RCT600
K243903 · Ray Co., Ltd. · Mar 2025
Green X 12 SE (PHT-40CHS)
K243088 · VATECH Co., Ltd. · Feb 2025
Green X 21 (PHT-90CHO)
K243081 · VATECH Co., Ltd. · Feb 2025