Cleared Traditional

K092182 - VOYAGER COMPACT IMAGING SYSTEM

K092182 is an FDA 510(k) clearance for VOYAGER COMPACT IMAGING SYSTEM, manufactured by Ardent Sound, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K092182 · Ardent Sound, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
80d
Days
Class 2
Risk

K092182 is an FDA 510(k) clearance for the VOYAGER COMPACT IMAGING SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Ardent Sound, Inc. (Mesa, US). The FDA issued a Cleared decision on October 9, 2009 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Ardent Sound, Inc. devices

FDA 510(k) Submission Details - K092182

510(k) Number K092182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2009
Decision Date October 09, 2009
Days to Decision 80 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
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 525
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K092182.
A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
K101337 · Sonoscape Company Limited · Sep 2010
HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS
K093466 · Hitachi Medical Systems America, Inc. · Jun 2010
ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM
K093488 · Aloka Co., Ltd. · Nov 2009
S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM
K082229 · Volcano Corporation · Oct 2008
TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO
K080234 · Teratech Corp. · Feb 2008
ACUSON X300 ULTRASOUND SYSTEM
K072676 · Siemens Medical Solutions USA, Inc. · Dec 2007