Cleared Traditional

K161439 - E-CUBE 11

K161439 is an FDA 510(k) clearance for E-CUBE 11, manufactured by Alpinion Medical Systems Co., Ltd.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K161439 · Alpinion Medical Systems Co., Ltd. · Radiology device
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Sep 2016
Decision
120d
Days
Class 2
Risk

K161439 is an FDA 510(k) clearance for the E-CUBE 11. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Alpinion Medical Systems Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on September 21, 2016 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 Alpinion Medical Systems Co., Ltd. devices

FDA 510(k) Submission Details - K161439

510(k) Number K161439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2016
Decision Date September 21, 2016
Days to Decision 120 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
13d slower than avg
Panel avg: 107d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 873
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