510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980468Substantially Equivalent

Au5 Ultrasound Imaging System

Esaote North America, Inc, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980468 is the FDA 510(k) clearance record for AU5 ULTRASOUND IMAGING SYSTEM, a class II device, cleared for Biosound Esaote, Inc. on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list 20 510(k) clearances for Esaote North America, Inc, from to . As of , FDA records show no recalls naming K980468.

Clearance record

Decision date
Received
(201 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Biosound Esaote, Inc. 8000 Castleway Dr., Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code IYN

Trailing 12 months
52 clearances under product code IYN in the twelve months to October 2026, May 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code IYN, trailing twelve months
MonthClearances
November 20256
December 20256
January 20264
February 20261
March 20266
April 20263
May 202611
June 20263
July 20266
August 20263
September 20263
October 20260