510(k) · Cleared

Cleared

Univision Echocardiology System

K964803510(k) TraditionalCleared Feb 11, 199774-day reviewClass I21 CFR 892.2010

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

Network Concepts, Inc. · LMB Device, Digital Image Storage, Radiological

Cleared on Feb 11, 1997 as substantially equivalent to K950279 (Tomtec Imaging Systems, Inc., 1995) after a 74-day review. Its family tree reaches back 1 generation to 1995. 24 later devices descend from it.

Decided: Feb 11, 1997
Review: 74 days
Class: Class I
Product code: LMB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K950279 (1995). 24 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK950279 TOMTECP90Tomtec Imaging Systems, Inc. · 1995
This deviceK964803 Univision Echocardiology SystemNetwork Concepts, Inc. · 1997
Descendant · cites it directly · 23 of its ownK980060 EcholinkMpacs, LLC · 1998
Descendant · 2 generations on · 16 of its ownK023772 Kinetdx Picture Archiving and Communications SystemAcuson Corp. · 2002 · Recalled
Descendant · 2 generations on · 16 of its ownK992259 Echocardiography System Series 95000Camtronics, Ltd. · 1999
Descendant · 3 generations on · 13 of its ownK041029 KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · Recalled
Descendant · 4 generations on · 7 of its ownK053133 Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · Recalled

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

1998high 4 (2005) · low 0 (2000)2026

Most influential descendants

Showing 5 of 24 · See all

K980060EcholinkMpacs, LLC · 1998 · cites it directly23descendants
K023772Kinetdx Picture Archiving and Communications SystemAcuson Corp. · 2002 · 2 generations on16descendants
K992259Echocardiography System Series 95000Camtronics, Ltd. · 1999 · 2 generations on16descendants
K041029KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · 3 generations on13descendants
K053133Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · 4 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950279	TOMTECP90	Tomtec Imaging Systems, Inc.	1995	—
0 (this device)	K964803	Univision Echocardiology System	Network Concepts, Inc.	1997	—
+1	K980060	Echolink	Mpacs, LLC	1998	—
+2	K023772	Kinetdx Picture Archiving and Communications System	Acuson Corp.	2002	5
+2	K992259	Echocardiography System Series 95000	Camtronics, Ltd.	1999	—
+3	K041029	Kinetdx	Siemens Medi Cal Solutions, Inc.	2004	1
+4	K053133	Syngo Dynamics, Version 5.0	Siemens Medical Solutions USA, Inc.	2005	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2002	1	0
2003	3	0
2004	2	0
2005	4	0
2006	1	0
2010	1	0
2011	2	0
2012	1	0
2016	1	0
2018	1	0
2019	1	0
2021	1	0
2022	1	0
2024	1	0

FIG. 1 — Lineage of K964803, 1995–2024Source: 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 LMB? 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

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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
*	K950279	TOMTECP90 Summary page 1 …tside the exam room and long term storage and retrieval on digital media. The substantial equivalent device is TomTec Imaging Systems’ TomTec P90 system, FDA 510K Number K950279. DEVICE DESCRIPTION: UNIVISION™ Echocardiology System is a real-time network system that provides review of echocardiograms eit…	Tomtec Imaging Systems, Inc.	1995	—

Also cleared against K950279: 3 other devices →

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K980060	Echolink	Mpacs, LLC	1998	23
K990052	Tel-Echo System	Innovative Medical Solutions, Inc.	1999	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?

Its one ancestor has no recall.
Of its descendants, K980060 (Mpacs, LLC, 1998) has gone furthest, with 23 descendants of its own.
3 other devices also cite its predicate K950279.

How does its category compare?

All LMB devices

LMB Device, Digital Image Storage, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMB

FDA has decided no LMB device since 2007.

Median 510(k) review, days · LMB

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

Recalls per year · LMB

1in 2013

2007high 5 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LMB

7in 2025

2007high 21 (2016) · low 0 (2015)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	1
2008	—	1	3
2009	—	5	3
2010	—	0	16
2011	—	2	4
2012	—	0	4
2013	—	1	7
2014	—	0	1
2015	—	0	0
2016	—	0	21
2017	—	0	10
2018	—	0	5
2019	—	0	10
2020	—	0	8
2021	—	0	10
2022	—	0	0
2023	—	0	10
2024	—	0	9
2025	—	0	7
2026	—	0	—

What is it indicated for?

The UNIVISION™ Echocardiology System is a network system intended to use digital technology to acquire images from an echocardiogaphy ultrasound system for viewing outside the exam room and long term storage and retrieval on digital media.

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/K964803 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964803: Univision Echocardiology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964803

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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