510(k) · Cleared

Cleared

Viewmate Ultrasound Imaging System

K031066510(k) TraditionalCleared Oct 17, 2003197-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

Ep Medsystems · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Oct 17, 2003 after a 197-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 691 later devices descend from it.

Decided: Oct 17, 2003
Review: 197 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 0

691 later devices descend from it, 5 citing it directly.

This deviceK031066 Viewmate Ultrasound Imaging SystemEp Medsystems · 2003
Descendant · cites it directly · 687 of its ownK062247 HD11 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2006 · Recalled
Descendant · 2 generations on · 584 of its ownK080935 Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008
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 691 descendants. See all descendants

Descendants cleared per year

2006high 63 (2017) · low 2 (2006)2026

Most influential descendants

Showing 5 of 691 · See all

K062247HD11 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2006 · cites it directly687descendants
K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008 · 2 generations on584descendants
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
0 (this device)	K031066	Viewmate Ultrasound Imaging System	Ep Medsystems	2003	—
+1	K062247	HD11 Diagnostic Ultrasound System	Philips Ultrasound, Inc.	2006	3
+2	K080935	Sonix MDP Ultrasound Scanner	Ultrasonix Medical Corporation	2008	—
+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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2007	2	0
2008	8	0
2009	6	0
2010	11	0
2011	16	0
2012	23	0
2013	23	0
2014	35	0
2015	39	0
2016	43	0
2017	63	0
2018	55	0
2019	38	0
2020	55	0
2021	39	0
2022	46	0
2023	41	0
2024	50	0
2025	57	0
2026	39	0

FIG. 1 — Lineage of K031066, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (691)

See all 691

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

Number	Device	Applicant	Decided	Descendants
K062247	HD11 Diagnostic Ultrasound System	Philips Ultrasound, Inc.	2006	687
K071028	Viewmate System	Ep Medsystems	2007	134
K073709	Modification to Viewmate System	Ep Medsystems	2008	133
K101091	Z.One Ultra Ultrasound System	Zonare Medical Systems, Inc.	2010	132
K062340	Cardiooptics Augmentative Cardiac Optical Imaging System	Cardio-Optics, Inc.	2006	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?

Of its descendants, K062247 (Philips Ultrasound, Inc., 2006) has gone furthest, with 687 descendants of its own.

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 ViewMate@System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

The ViewMate8System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K031066 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031066: Viewmate 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/K031066

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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