Cleared Traditional

K121729 - E-CUBE 7

K121729 is an FDA 510(k) clearance for E-CUBE 7, 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 100-day FDA review.

K121729 · Alpinion Medical Systems Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
100d
Days
Class 2
Risk

K121729 is an FDA 510(k) clearance for the E-CUBE 7. 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. (Kirkland, US). The FDA issued a Cleared decision on September 20, 2012 after a review of 100 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 - K121729

510(k) Number K121729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2012
Decision Date September 20, 2012
Days to Decision 100 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
7d faster than avg
Panel avg: 107d · This submission: 100d
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
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K121729.
LOGIQ S7 EXPERT, LOGIQ S7 PRO
K122114 · Ge Healthcare · Oct 2012
ACUSON
K122825 · Siemens Medical Solutions USA, Inc. · Sep 2012
VOLUSON E6/E8/E8EXPERT/E10
K122327 · Ge Healthcare · Sep 2012
VIAMO SSA-640A V4.0
K122491 · Toshibamedical Systems Corporation · Sep 2012
VOLUSON P6, VOLUSON P8
K122387 · Ge Healthcare · Sep 2012
UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM
K122583 · Samsung Medison Co., Ltd. · Sep 2012