Cleared Traditional

ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM (K083254) - FDA 510(k) Clearance

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

K083254 · Aloka Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
45d
Days
Class 2
Risk

K083254 is an FDA 510(k) clearance for the ALOKA PROUSOUND 2 DIAGNOSTIC 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 Aloka Co., Ltd. (Wallingford, US). The FDA issued a Cleared decision on December 19, 2008 after a review of 45 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 Aloka Co., Ltd. devices

Submission Details

510(k) Number K083254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2008
Decision Date December 19, 2008
Days to Decision 45 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
62d faster than avg
Panel avg: 107d · This submission: 45d
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 540
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K083254.
SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
K102017 · Siemens Medical Solutions USA, Inc. · Sep 2010
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K093812 · Siemens Medical Solutions USA, Inc. · Mar 2010
ACUSON P50 ULTRASOUND SYSTEM
K083114 · Siemens Medical Solutions USA, Inc. · Mar 2009
GE VIVID E9 ULTRASOUND
K081921 · General Electric Co. · Aug 2008
GE LOGIQ P6
K073297 · General Electric Co. · Dec 2007
MODIFICATION TO GE LOGIQ A3
K072075 · General Electric Co. · Aug 2007