510(k) · Cleared

Cleared

TOMTECP90

K950279510(k) TraditionalCleared Sep 15, 1995234-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

Tomtec Imaging Systems, Inc. · LMB Device, Digital Image Storage, Radiological

Cleared on Sep 15, 1995 after a 234-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 26 later devices descend from it.

Decided: Sep 15, 1995
Review: 234 days
Class: Class I
Product code: LMB
Recalls: None
Predicates: 0

26 later devices descend from it, 4 citing it directly.

This deviceK950279 TOMTECP90Tomtec Imaging Systems, Inc. · 1995
Descendant · cites it directly · 24 of its ownK964803 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

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

1997high 4 (2005) · low 0 (2000)2026

Most influential descendants

Showing 5 of 26 · See all

K964803Univision Echocardiology SystemNetwork Concepts, Inc. · 1997 · cites it directly24descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K950279	TOMTECP90	Tomtec Imaging Systems, Inc.	1995	—
+1	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
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 K950279, 1995–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (26)

See all 26

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

Number	Device	Applicant	Decided	Descendants
K964803	Univision Echocardiology System	Network Concepts, Inc.	1997	24
K980060	Echolink	Mpacs, LLC	1998	23
K030242	Fyrelink	Mpacs, LLC	2003	0
K963936	Accesspoint, Med E-Mail, Dicom Reader	Biosound, Inc.	1997	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, K964803 (Network Concepts, Inc., 1997) has gone furthest, with 24 descendants of its own.

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	—

https://510kreport.com/device/K950279 · printed Nov 3, 2026

Cite this page

510(k) Report. “K950279: TOMTECP90.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K950279

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026