Cleared Traditional

VIVID I AND VIVID Q (K082374) - FDA 510(k) Clearance

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

K082374 · Ge Medical Systems Israel, Ultrasound, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
15d
Days
Class 2
Risk

K082374 is an FDA 510(k) clearance for the VIVID I AND VIVID Q. 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 Ge Medical Systems Israel, Ultrasound, Ltd. (Tirat Carmel, IL). The FDA issued a Cleared decision on September 2, 2008 after a review of 15 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 Ge Medical Systems Israel, Ultrasound, Ltd. devices

Submission Details

510(k) Number K082374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2008
Decision Date September 02, 2008
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
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 633
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K082374.
APLIO ARTIDA V2.0 SSH-880CV
K090158 · Toshiba America Medical Systems, In.C · Feb 2009
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K083505 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2008
M5 DIAGNOSTIC ULTRASOUND SYSTEM
K083001 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2008
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0
K082119 · Toshiba America Medical Systems, In.C · Aug 2008
GE VIVID E9 ULTRASOUND
K081921 · General Electric Co. · Aug 2008
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2
K081065 · Toshiba America Medical Systems, In.C · Jun 2008