Cleared Traditional

K200976 - SR-8230, SR-8230S Portable X-ray Unit (FDA 510(k) Clearance)

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

K200976 · Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · Radiology device
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Jun 2020
Decision
58d
Days
Class 2
Risk

K200976 is an FDA 510(k) clearance for the SR-8230, SR-8230S Portable X-ray Unit. 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 June 10, 2020 after a review of 58 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) devices

Submission Details

510(k) Number K200976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2020
Decision Date June 10, 2020
Days to Decision 58 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
49d faster than avg
Panel avg: 107d · This submission: 58d
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

All 233
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