Cleared Traditional

K093395 - OLYMPUS GF TYPE UC180

K093395 is the FDA 510(k) clearance for OLYMPUS GF TYPE UC180 by Olympus Medical Systems Corporation. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K093395 · Olympus Medical Systems Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
230d
Days
Class 2
Risk

K093395 is an FDA 510(k) clearance for the OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTR.... 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 Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on June 17, 2010 after a review of 230 days - an extended review 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: 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 Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K093395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2009
Decision Date June 17, 2010
Days to Decision 230 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
123d slower than avg
Panel avg: 107d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 779
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K093395.
SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
K102017 · Siemens Medical Solutions USA, Inc. · Sep 2010
GE LOGIQ P5 MODEL H44662LD
K101878 · Ge Healthcare · Aug 2010
MYLABTWICE, MODEL 6200
K100931 · Esaote, S.P.A. · Jun 2010
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K100830 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 2010
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K093812 · Siemens Medical Solutions USA, Inc. · Mar 2010
IU22 ULTRASOUND SYSTEM AND TRANSDUCERS
K093563 · Philips Ultrasound, Inc. · Feb 2010