Cleared Special

K033139 - GE MARLIN ULTRASOUND

K033139 is the FDA 510(k) clearance for GE MARLIN ULTRASOUND by General Electric Co.. It is a Class 2 Radiology device (product code IYN) cleared through the Special 510(k) pathway after a 23-day FDA review.

K033139 · General Electric Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
23d
Days
Class 2
Risk

K033139 is an FDA 510(k) clearance for the GE MARLIN ULTRASOUND. 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 General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on October 23, 2003 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all General Electric Co. devices

Submission Details

510(k) Number K033139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date October 23, 2003
Days to Decision 23 days
Submission Type Special
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
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 789
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K033139.
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
K034003 · Philips Ultrasound, Inc. · Jan 2004
FUKUDA DENSHI MODEL FF SONIC UF-750XT
K033209 · Fukuda Denshi USA, Inc. · Oct 2003
ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM
K033311 · Aloka Co., Ltd. · Oct 2003
GE LOGIQ BOOK
K032477 · General Electric Co. · Oct 2003
GE LOGIQ 5 PRO OR EXPERT
K032974 · General Electric Co. · Oct 2003
SONOLINE ANTARES WITH CLARIFY VE
K033196 · Siemens Medical Solutions USA, Inc. · Oct 2003