510(k) · Cleared
ClearedTomtec Echo-View
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomtec Tomographic Technologies GmbH · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jan 25, 1995 after a 518-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 of the 1,290 devices in its family, counting itself, have a Class I recall. 1,289 later devices descend from it.
- Decided
- Jan 25, 1995
- Review
- 518 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
1,289 later devices descend from it, 2 citing it directly. 8 of the 1,290 devices in this family, counting this one, have a Class I recall.
- This deviceK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- Descendant · cites it directly · 1,070 of its ownK992580 Fetal Assessment CapAcuson Corp. · 1999
- Descendant · 2 generations on · 1,069 of its ownK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- Descendant · 3 generations on · 1,003 of its ownK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- Descendant · 4 generations on · 988 of its ownK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- Descendant · cites it directly · 987 of its ownK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
Showing 5 of 1,289 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 1,289 · See all- K992580Fetal Assessment CapAcuson Corp. · 1999 · cites it directly1,070descendants
- K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002 · 2 generations on1,069descendants
- K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003 · 3 generations on1,003descendants
- K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · 4 generations on988descendants
- K993398Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999 · cites it directly987descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| +1 | K992580 | Fetal Assessment Cap | Acuson Corp. | 1999 | — |
| +2 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| +3 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +4 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +1 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 12 | 0 |
| 2005 | 16 | 0 |
| 2006 | 14 | 0 |
| 2007 | 18 | 0 |
| 2008 | 29 | 0 |
| 2009 | 28 | 0 |
| 2010 | 30 | 0 |
| 2011 | 41 | 0 |
| 2012 | 48 | 0 |
| 2013 | 59 | 0 |
| 2014 | 67 | 0 |
| 2015 | 72 | 0 |
| 2016 | 75 | 1 |
| 2017 | 88 | 2 |
| 2018 | 82 | 1 |
| 2019 | 62 | 0 |
| 2020 | 93 | 2 |
| 2021 | 66 | 0 |
| 2022 | 73 | 0 |
| 2023 | 69 | 0 |
| 2024 | 75 | 0 |
| 2025 | 99 | 2 |
| 2026 | 66 | 0 |
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.
8 devices in this family have a Class I recall. 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (1,289)
See all 1,2892 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K172258Novasight Hybrid SystemConavi Medical, Inc. · 2018 · 6 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc. · 2020 · 9 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 10 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 10 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 11 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 12 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- Of its descendants, K992580 (Acuson Corp., 1999) has gone furthest, with 1,070 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
https://510kreport.com/device/K934139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934139: Tomtec Echo-View.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934139
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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