Cleared Traditional

K251798 - RCT700

K251798 is an FDA 510(k) clearance for RCT700, manufactured by Ray Co., Ltd.. The device is a Class 2 Radiology device with product code OAS cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K251798 · Ray Co., Ltd. · Radiology device
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Nov 2025
Decision
166d
Days
Class 2
Risk

K251798 is an FDA 510(k) clearance for the RCT700. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Ray Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on November 25, 2025 after a review of 166 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 Ray Co., Ltd. devices

FDA 510(k) Submission Details - K251798

510(k) Number K251798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2025
Decision Date November 25, 2025
Days to Decision 166 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
59d slower than avg
Panel avg: 107d · This submission: 166d
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 126
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K251798.
RCT800
K260462 · Ray Co., Ltd. · Apr 2026
myray ProXIma X6
K252353 · Cefla S.C. · Mar 2026
Primevision 3D
K253959 · Dentsply Sirona · Feb 2026
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