Cleared Traditional

K121062 - VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM

K121062 is an FDA 510(k) clearance for VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, manufactured by Ge Medical System Israel , Ltd.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K121062 · Ge Medical System Israel , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
133d
Days
Class 2
Risk

K121062 is an FDA 510(k) clearance for the VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Ge Medical System Israel , Ltd. (Wauwatosa, US). The FDA issued a Cleared decision on August 17, 2012 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Ge Medical System Israel , Ltd. devices

FDA 510(k) Submission Details - K121062

510(k) Number K121062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2012
Decision Date August 17, 2012
Days to Decision 133 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 107d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 257
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K121062.
MDU5 PLUS STERILE BAG
K123424 · Boston Scientific Corp · Feb 2013
C1-6-D ULTRASOUND TRANSDUCER
K122921 · Ge Healthcare · Oct 2012
C2-9-D ULTRASOUND TRANSDUCER
K122515 · Ge Healthcare · Sep 2012
V5MS TRANSDUCER
K121807 · Siemens Medical Solutions USA, Inc. · Jul 2012
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K110999 · Edan Instruments, Inc. · Apr 2011
FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
K110202 · Fujifilm Medical System U.S.A., Inc. · Feb 2011