Cleared Traditional

Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) (K201800) - FDA 510(k) Clearance

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

K201800 · Nanoray Co., Ltd. · Radiology device
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Dec 2020
Decision
181d
Days
Class 2
Risk

K201800 is an FDA 510(k) clearance for the Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X). Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Nanoray Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on December 28, 2020 after a review of 181 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 Nanoray Co., Ltd. devices

Submission Details

510(k) Number K201800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2020
Decision Date December 28, 2020
Days to Decision 181 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
74d slower than avg
Panel avg: 107d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 Consultant

Wise Company, Inc.
Sanglok Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EHD Unit, X-ray, Extraoral With Timer

All 189
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K201800.
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