Cleared Traditional

TITAN HIGH RESOLUTION ULTRASOUND SYSTEM (K030949) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K030949 · Sonosite,Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
12d
Days
Class 2
Risk

K030949 is an FDA 510(k) clearance for the TITAN HIGH RESOLUTION 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 Sonosite,Inc. (Bothell, US). The FDA issued a Cleared decision on April 7, 2003 after a review of 12 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 Sonosite,Inc. devices

Submission Details

510(k) Number K030949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2003
Decision Date April 07, 2003
Days to Decision 12 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 107d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 535
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K030949.
SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM
K032114 · Siemens Medical Solutions USA, Inc. · Jul 2003
ACUSON CV70 CARDIOVASCULAR SYSTEM
K032111 · Siemens Medical Solutions USA, Inc. · Jul 2003
GE VIVID 7, MODEL FC0003XX
K031663 · General Electric Co. · Jun 2003
SONOLINE ANTARES ULTRASOUND SYSTEM
K023720 · Siemens Medical Solutions USA, Inc. · Nov 2002
GE VIVID 3 EXPERT
K020789 · General Electric Co. · Apr 2002
LOGIQ 3
K020263 · General Electric Co. · Feb 2002