Cleared Special

Dental Cone-beam Computed Tomography (K240855) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240855 · Yian Medical Technology (Haining) Co., Ltd. · Radiology device
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Apr 2024
Decision
28d
Days
Class 2
Risk

K240855 is an FDA 510(k) clearance for the Dental Cone-beam Computed Tomography. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Yian Medical Technology (Haining) Co., Ltd. (Haining, Jiaxing, CN). The FDA issued a Cleared decision on April 25, 2024 after a review of 28 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 Yian Medical Technology (Haining) Co., Ltd. devices

Submission Details

510(k) Number K240855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2024
Decision Date April 25, 2024
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
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 73
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K240855.
Dental Cone-beam Computed Tomography (FinScan F350)
K242805 · Changzhou Finno Medical Technology Co., Ltd. · Jan 2025
Orthopantomograph™ OP 3D LX (PAN 3D)
K241249 · Palodex Group OY · Sep 2024
T2 Plus
K233806 · Osstem Implant Co., Ltd. · Sep 2024
Dental Cone-beam Computed Tomography
K232710 · Yian Medical Technology (Haining) Co., Ltd. · Jan 2024
Planmeca Viso
K230985 · Planmeca Oy · Dec 2023
bright CT
K231181 · Dentium Co., Ltd (Ict Branch) · Dec 2023