510(k) · Cleared

Cleared

Viewmate System

K071028510(k) SpecialCleared May 1, 200720-day reviewClass I21 CFR 890.3675

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

Ep Medsystems · ITN Splint, Denis Brown

Cleared on May 1, 2007 as substantially equivalent to K031066 (Ep Medsystems, 2003) after a 20-day review. Its family tree reaches back 1 generation to 2003. 134 later devices descend from it.

Decided: May 1, 2007
Review: 20 days
Class: Class I
Product code: ITN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K031066 (2003). 134 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK031066 Viewmate Ultrasound Imaging SystemEp Medsystems · 2003
This deviceK071028 Viewmate SystemEp Medsystems · 2007
Descendant · cites it directly · 133 of its ownK073709 Modification to Viewmate SystemEp Medsystems · 2008
Descendant · 2 generations on · 132 of its ownK101091 Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc. · 2010
Descendant · 3 generations on · 98 of its ownK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
Descendant · 4 generations on · 96 of its ownK123622 AcusonSiemens Medical Solutions USA, Inc. · 2012 · Recalled
Descendant · 4 generations on · 74 of its ownK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled

Showing 5 of 134 descendants. See all descendants

Descendants cleared per year

2008high 13 (2022) · low 0 (2009)2026

Most influential descendants

Showing 5 of 134 · See all

K073709Modification to Viewmate SystemEp Medsystems · 2008 · cites it directly133descendants
K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc. · 2010 · 2 generations on132descendants
K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · 3 generations on98descendants
K123622AcusonSiemens Medical Solutions USA, Inc. · 2012 · 4 generations on96descendants
K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · 4 generations on74descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K031066	Viewmate Ultrasound Imaging System	Ep Medsystems	2003	—
0 (this device)	K071028	Viewmate System	Ep Medsystems	2007	—
+1	K073709	Modification to Viewmate System	Ep Medsystems	2008	—
+2	K101091	Z.One Ultra Ultrasound System	Zonare Medical Systems, Inc.	2010	—
+3	K121699	Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound…	Siemens Medical Solutions USA, Inc.	2012	—
+4	K123622	Acuson	Siemens Medical Solutions USA, Inc.	2012	13
+4	K123001	Acuson X700 Diagnstic Ultrasound System	Siemens Medical Solutions USA, Inc.	2012	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2010	1	0
2011	1	0
2012	5	0
2013	4	0
2014	10	0
2015	5	0
2016	8	0
2017	9	0
2018	9	0
2019	7	0
2020	12	0
2021	10	0
2022	13	0
2023	10	0
2024	11	0
2025	13	0
2026	5	0

FIG. 1 — Lineage of K071028, 2003–2026Source: 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 ITN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	K031066	Viewmate Ultrasound Imaging System Summary page 2 …ardiac ultrasound imaging console in combination with the ViewFlexTM1 ultrasound catheter was cleared for US marketing on October 17, 2003 (K031066). As of this writing, there have been no significant modifications to any element of the ViewMate® System: therefo…	Ep Medsystems	2003	—

Also cleared against K031066: 4 other devices →

What descends from it? (134)

See all 134

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K073709	Modification to Viewmate System	Ep Medsystems	2008	133

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, K073709 (Ep Medsystems, 2008) has gone furthest, with 133 descendants of its own.
4 other devices also cite its predicate K031066.

How does its category compare?

All ITN devices

ITN Splint, Denis Brown: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · ITN

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITN

Too few ITN 510(k)s in any year since 2007 to give a median.

Recalls per year · ITN

No recall names ITN since 2007.

Adverse event reports per year · ITN

No MAUDE report names ITN since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071028 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071028: Viewmate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071028

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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