Cleared Traditional

SR-8100 Portable X-ray Unit (K200637) - FDA 510(k) Clearance

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

K200637 · Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · Radiology device
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Jul 2020
Decision
121d
Days
Class 2
Risk

K200637 is an FDA 510(k) clearance for the SR-8100 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 July 9, 2020 after a review of 121 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 K200637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2020
Decision Date July 09, 2020
Days to Decision 121 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
14d slower than avg
Panel avg: 107d · This submission: 121d
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 95
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K200637.
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K200976 · Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · Jun 2020