Cleared Traditional

K181277 - E-CUBE 12

K181277 is an FDA 510(k) clearance for E-CUBE 12, 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 137-day FDA review.

K181277 · Alpinion Medical Systems Co., Ltd. · Radiology device
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Sep 2018
Decision
137d
Days
Class 2
Risk

K181277 is an FDA 510(k) clearance for the E-CUBE 12. 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 28, 2018 after a review of 137 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 - K181277

510(k) Number K181277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2018
Decision Date September 28, 2018
Days to Decision 137 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
30d slower than avg
Panel avg: 107d · This submission: 137d
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 1097
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K181277.
Xperius Ultrasound System
K182529 · Philips Ultrasound, Inc. · Oct 2018
Vivid S60N, Vivid S70N
K182450 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Oct 2018
E-CUBE 8
K181617 · Alpinion Medical Systems Co., Ltd. · Oct 2018
LOGIQ P9
K181783 · Ge Healthcare · Sep 2018
BenQ Diagnostic Ultrasound System
K181313 · Qisda Corporation · Aug 2018
CBit Series Digital Color Doppler Ultrasound System
K180974 · CHISON Medical Technologies Co., Ltd. · Aug 2018