Cleared Traditional

K000931 - AU5 ULTRASOUND IMAGING SYSTEM

K000931 is an FDA 510(k) clearance for AU5 ULTRASOUND IMAGING SYSTEM, manufactured by Biosound Esaote, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K000931 · Biosound Esaote, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
78d
Days
Class 2
Risk

K000931 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 June 8, 2000 after a review of 78 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 Biosound Esaote, Inc. devices

FDA 510(k) Submission Details - K000931

510(k) Number K000931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2000
Decision Date June 08, 2000
Days to Decision 78 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 107d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

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 919
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K000931.
ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM
K001400 · Siemens Medical Solutions USA, Inc. · Aug 2000
SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM
K002185 · Medison America, Inc. · Aug 2000
M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1
K001711 · Agilent Technologies, Inc. · Jun 2000
GE SYSTEM FIVE
K001267 · Ge Medical Systems, Inc. · May 2000
EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER
K994026 · Hitachi Medical Corp. of America · Mar 2000
7250 (MEGAS)
K994369 · Biosound Esaote, Inc. · Feb 2000