510(k) · Cleared

Cleared

AU5 Ultrasound Imaging System

K980468510(k) TraditionalCleared Aug 26, 1998201-day reviewClass II21 CFR 892.1550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biosound Esaote, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Aug 26, 1998 as substantially equivalent to K944485 (Biosound, Inc., 1995) after a 201-day review. Its family tree reaches back 1 generation to 1995. 85 later devices descend from it.

Decided: Aug 26, 1998
Review: 201 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K944485 (1995). 85 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK944485 4000 AU Ultrasound Imaging SystemBiosound, Inc. · 1995
This deviceK980468 AU5 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998
Descendant · cites it directly · 83 of its ownK990360 AU6Biosound Esaote, Inc. · 1999
Descendant · 2 generations on · 71 of its ownK014168 AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D…Biosound Esaote, Inc. · 2002
Descendant · 3 generations on · 67 of its ownK040596 Ultrasound Imaging System, Model 7300Esaote, S.p.A. · 2004 · Recalled
Descendant · 4 generations on · 66 of its ownK050326 7350 Ultrasound Imaging System, Model 7350Esaote, S.p.A. · 2005 · Recalled
Descendant · 3 generations on · 66 of its ownK023255 Technos MP, Model AU6Biosound Esaote, Inc. · 2003

Showing 5 of 85 descendants. See all descendants

Descendants cleared per year

1999high 6 (2005) · low 0 (2000)2026

Most influential descendants

Showing 5 of 85 · See all

K990360AU6Biosound Esaote, Inc. · 1999 · cites it directly83descendants
K014168AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging Mode and…Biosound Esaote, Inc. · 2002 · 2 generations on71descendants
K040596Ultrasound Imaging System, Model 7300Esaote, S.p.A. · 2004 · 3 generations on67descendants
K0503267350 Ultrasound Imaging System, Model 7350Esaote, S.p.A. · 2005 · 4 generations on66descendants
K023255Technos MP, Model AU6Biosound Esaote, Inc. · 2003 · 3 generations on66descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K944485	4000 AU Ultrasound Imaging System	Biosound, Inc.	1995	—
0 (this device)	K980468	AU5 Ultrasound Imaging System	Biosound Esaote, Inc.	1998	—
+1	K990360	AU6	Biosound Esaote, Inc.	1999	—
+2	K014168	AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging…	Biosound Esaote, Inc.	2002	—
+3	K040596	Ultrasound Imaging System, Model 7300	Esaote, S.p.A.	2004	4
+4	K050326	7350 Ultrasound Imaging System, Model 7350	Esaote, S.p.A.	2005	1
+3	K023255	Technos MP, Model AU6	Biosound Esaote, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0
2002	1	0
2003	1	0
2004	1	0
2005	6	0
2006	3	0
2007	2	0
2008	2	0
2009	3	0
2010	2	0
2011	5	0
2012	3	0
2013	2	0
2014	6	0
2016	6	0
2017	5	0
2018	4	0
2019	6	0
2020	5	0
2021	2	0
2022	2	0
2023	2	0
2024	3	0
2025	6	0
2026	5	0

FIG. 1 — Lineage of K980468, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IYN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IYN device

#1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K944485	4000 AU Ultrasound Imaging System Summary page 1 …asound Imaging System Classification Name(s): System, Imaging, Pulsed Doppler, Ultrasonic Classification Number: 90IYN; 90IYO 807.92(a)(3) Predicate Device(s) Esaote AU4 K944485 Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table. 97 === P…	Biosound, Inc.	1995	—

Also cleared against K944485: 2 other devices →

What descends from it? (85)

See all 85

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K990360	AU6	Biosound Esaote, Inc.	1999	83
K013142	Diasus	Dynamic Imaging, Ltd.	2001	10
K050551	Voyager Personal Imaging Device	Ardent Sound, Inc.	2005	8
K060800	Seeker/Spark Ultrasound System	Ardent Sound, Inc.	2006	2
K092182	Voyager Compact Imaging System	Ardent Sound, Inc.	2009	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K990360 (Biosound Esaote, Inc., 1999) has gone furthest, with 83 descendants of its own.
2 other devices also cite its predicate K944485.

How does its category compare?

All IYN devices

IYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYN

57in 2025

2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007high 124 (2025) · low 18 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYN

10in 2025

2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	13	26	16	3
2008	25	18	12	2
2009	18	29	8	9
2010	29	67	10	17
2011	39	46	8	18
2012	43	37	3	20
2013	51	60	8	18
2014	56	39	2	48
2015	54	55	3	116
2016	60	56	2	145
2017	64	83	0	146
2018	59	85	7	85
2019	47	79	0	59
2020	57	72	4	67
2021	46	105	8	213
2022	53	105	10	186
2023	44	115	4	229
2024	50	119	1	266
2025	57	124	10	610
2026	44	107	2 (1)	—

What is it indicated for?

The AUS ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vessel and fetal applications.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980468 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980468: AU5 Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980468

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026