Cleared Traditional

K132228 - UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM

K132228 is the FDA 510(k) clearance for UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM by Samsung Medison Co., Ltd.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K132228 · Samsung Medison Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
34d
Days
Class 2
Risk

K132228 is an FDA 510(k) clearance for the UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Samsung Medison Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on August 20, 2013 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Samsung Medison Co., Ltd. devices

Submission Details

510(k) Number K132228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2013
Decision Date August 20, 2013
Days to Decision 34 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 107d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 Consultant

Regulatory Technology Services, LLC

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 408
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K132228.
CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE
K133641 · Volcano Corporation · Dec 2013
VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION
K133142 · Volcano Corporation · Nov 2013
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K131830 · Edan Instruments, Inc. · Sep 2013
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K131690 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2013
ILAB ULTRASOUND IMAGING SYSTEM
K130243 · Boston Scientific Corp · Mar 2013
ILAB ULTRASOUND IMAGING SYSTEM
K123535 · Boston Scientific Corp · Jan 2013