Cleared Traditional

K130803 - UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM

K130803 is an FDA 510(k) clearance for UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM, manufactured by Samsung Medison Co., Ltd.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K130803 · Samsung Medison Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
21d
Days
Class 2
Risk

K130803 is an FDA 510(k) clearance for the UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM. 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 Samsung Medison Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on April 12, 2013 after a review of 21 days - a notably fast clearance cycle.

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: 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

FDA 510(k) Submission Details - K130803

510(k) Number K130803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2013
Decision Date April 12, 2013
Days to Decision 21 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
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1101
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K130803.
TERASON USMART3200T ULTRASOUND SYSTEM
K131209 · Teratech Corp. · May 2013
PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0
K122537 · Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical · Apr 2013
PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K130119 · Sonoscape Company Limited · Apr 2013
NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM
K130308 · Hitachi Aloka Medical, Ltd. · Apr 2013
SPEQRT ULTRASOUND SYSTEM
K130659 · Signostics Pty, Ltd. · Apr 2013
SONOSITE MAXX SERIES ULTRASOUND SYSTEM
K130173 · FUJIFILM Sonosite, Inc. · Mar 2013