Cleared Traditional

K202353 - SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System (FDA 510(k) Clearance)

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

K202353 · Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · Radiology device
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Dec 2020
Decision
127d
Days
Class 2
Risk

K202353 is an FDA 510(k) clearance for the SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) (Shantou, CN). The FDA issued a Cleared decision on December 23, 2020 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) devices

Submission Details

510(k) Number K202353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2020
Decision Date December 23, 2020
Days to Decision 127 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 107d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

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