Cleared Traditional

AU5 ULTRASOUND IMAGING SYSTEM (K980468) - FDA 510(k) Clearance

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

K980468 · Biosound Esaote, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
201d
Days
Class 2
Risk

K980468 is an FDA 510(k) clearance for the AU5 ULTRASOUND IMAGING 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 Biosound Esaote, Inc. (Indianapolis, US). The FDA issued a Cleared decision on August 26, 1998 after a review of 201 days - an extended review 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: 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 Biosound Esaote, Inc. devices

Submission Details

510(k) Number K980468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1998
Decision Date August 26, 1998
Days to Decision 201 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
94d slower than avg
Panel avg: 107d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 609
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K980468.
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K003125 · Siemens Medical Solutions USA, Inc. · Oct 2000
ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM
K001400 · Siemens Medical Solutions USA, Inc. · Aug 2000
SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O
K990339 · Hewlett-Packard Co. · Feb 1999
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING
K980557 · Siemens Medical Solutions USA, Inc. · Apr 1998
LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM
K960527 · GE Medical Systems · Sep 1997
GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM
K964886 · GE Medical Systems · Jul 1997