510(k) · Cleared

Cleared

Ergosonix Ultrasound Scanner, Modulo Ultrasound Scanner

K042326510(k) TraditionalCleared Sep 16, 200420-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

Ultrasonix Medical Corporation · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Sep 16, 2004 as substantially equivalent to K020630 (Ultrasonix Medical Corporation, 2002) and 2 other predicates after a 20-day review. Its family tree reaches back 3 generations to 1995. 590 later devices descend from it.

Decided: Sep 16, 2004
Review: 20 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K935595 (1995). 4 ancestors in all. 590 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 3 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
2 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
1 generation backK020630 Ultrasonix Ergosonix 500 Ultrasound ScannerUltrasonix Medical Corporation · 2002
This deviceK042326 Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerUltrasonix Medical Corporation · 2004
Descendant · cites it directly · 584 of its ownK080935 Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008
Descendant · cites it directly · 583 of its ownK080223 Zura Tee SystemImacor, LLC · 2008 · Recalled
Descendant · 2 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
Descendant · 3 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
Descendant · 4 generations on · 472 of its ownK110943 Logiq E9GE Healthcare · 2011 · Recalled

Showing 5 of 590 descendants. See all descendants

Descendants cleared per year

2008high 52 (2020) · low 3 (2008)2026

Most influential descendants

Showing 5 of 590 · See all

K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008 · cites it directly584descendants
K080223Zura Tee SystemImacor, LLC · 2008 · cites it directly583descendants
K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 2 generations on582descendants
K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 3 generations on569descendants
K110943Logiq E9GE Healthcare · 2011 · 4 generations on472descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K935595	Acuson Model 3001	Acuson Corp.	1995	—
−2	K973767	Harmonic Imaging with Contrast	Acuson Corp.	1997	—
−1	K020630	Ultrasonix Ergosonix 500 Ultrasound Scanner	Ultrasonix Medical Corporation	2002	—
0 (this device)	K042326	Ergosonix Ultrasound Scanner, Modulo Ultrasound Scanner	Ultrasonix Medical Corporation	2004	—
+1	K080935	Sonix MDP Ultrasound Scanner	Ultrasonix Medical Corporation	2008	—
+1	K080223	Zura Tee System	Imacor, LLC	2008	1
+2	K083095	Sonixtouch Ultrasound System	Ultrasonix Medical Corporation	2008	—
+3	K092271	GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4	GE Healthcare	2009	1
+4	K110943	Logiq E9	GE Healthcare	2011	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	3	0
2009	3	0
2010	5	0
2011	11	0
2012	21	0
2013	19	0
2014	34	0
2015	29	0
2016	37	0
2017	49	0
2018	49	0
2019	36	0
2020	52	0
2021	38	0
2022	43	0
2023	38	0
2024	45	0
2025	47	0
2026	31	0

FIG. 1 — Lineage of K042326, 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? (3)

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
*	K020630	Ultrasonix Ergosonix 500 Ultrasound Scanner Summary page 2 …Page 8 of 37 2.4 Classification Class Ila 2.5 Predicate Device: Ultrasonix Ergosonix 500 Ultrasound Scanner (K020630) ATL HDI 5000 System (K002003) Acuson Sequoia (K973767) 2.6 Reason for submission: Clearance request for new transduce…	Ultrasonix Medical Corporation	2002	—
*	K002003	Hdi 5000 Ultrasound System with Extended Field of View Imaging Summary page 2 …Page 8 of 37 2.4 Classification Class Ila 2.5 Predicate Device: Ultrasonix Ergosonix 500 Ultrasound Scanner (K020630) ATL HDI 5000 System (K002003) Acuson Sequoia (K973767) 2.6 Reason for submission: Clearance request for new transducers, new applications and a new mo…	Atl Ultrasound, Inc.	2000	—
*	K973767	Harmonic Imaging with Contrast Summary page 2 …=== 2.4 Classification Class Ila 2.5 Predicate Device: Ultrasonix Ergosonix 500 Ultrasound Scanner (K020630) ATL HDI 5000 System (K002003) Acuson Sequoia (K973767) 2.6 Reason for submission: Clearance request for new transducers, new applications and a new mode Transducers:…	Acuson Corp.	1997	—

Also cleared against K020630: 2 other devices →

What descends from it? (590)

See all 590

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

Number	Device	Applicant	Decided	Descendants
K080935	Sonix MDP Ultrasound Scanner	Ultrasonix Medical Corporation	2008	584
K080223	Zura Tee System	Imacor, LLC	2008	583
K113613	Digital Color Doppler Ultrasound Imaging System	Shantou Institute of Ultrasonic Instuments	2012	5
K100989	Zura Tee System with Claritee Probe	Imacor, Inc.	2010	1
K092907	Digital Ultrasound Imaging System, Convex Array Transducer, Linear Array Transducer…	Shantou Institute of Ultrasonic Instuments	2010	1

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?

The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K080935 (Ultrasonix Medical Corporation, 2008) has gone furthest, with 584 descendants of its own.
2 other devices also cite its predicate K020630.

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 Ergosonix and Modulo Ultrasound Scanners are intended for use in obstetrics/gynecology, general radiology, cardiac examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), trans-vaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric), transcranial, transesophageal.

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/K042326 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042326: Ergosonix Ultrasound Scanner, Modulo Ultrasound Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042326

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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