510(k) · Cleared
ClearedEcho View, Easy View, Omni View
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomtec Imaging Systems GmbH · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Nov 5, 1999 as substantially equivalent to K934139 (Tomtec Tomographic Technologies GmbH, 1995) after a 28-day review. Its family tree reaches back 1 generation to 1995. 8 of the 989 devices in its family, counting itself, have a Class I recall. 987 later devices descend from it.
- Decided
- Nov 5, 1999
- Review
- 28 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934139 (1995). 987 later devices descend from it, 1 citing it directly. 8 of the 989 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- This deviceK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- Descendant · cites it directly · 986 of its ownK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- Descendant · 2 generations on · 882 of its ownK042540 Philips IU22 Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 588 of its ownK093563 IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 527 of its ownK102041 AixplorerSupersonic Imagine · 2010
- Descendant · 5 generations on · 525 of its ownK112255 AixplorerSupersonic Imagine · 2012
Showing 5 of 987 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 987 · See all- K022824Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X & Surgical…Tomtec Imaging Systems GmbH · 2002 · cites it directly986descendants
- K042540Philips IU22 Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · 2 generations on882descendants
- K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · 3 generations on588descendants
- K102041AixplorerSupersonic Imagine · 2010 · 4 generations on527descendants
- K112255AixplorerSupersonic Imagine · 2012 · 5 generations on525descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| 0 (this device) | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| +1 | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X… | Tomtec Imaging Systems GmbH | 2002 | — |
| +2 | K042540 | Philips IU22 Ultrasound System | Philips Ultrasound, Inc. | 2004 | 4 |
| +3 | K093563 | IU22 Ultrasound System and Transducers | Philips Ultrasound, Inc. | 2010 | 2 |
| +4 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| +5 | K112255 | Aixplorer | Supersonic Imagine | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 21 | 0 |
| 2009 | 13 | 0 |
| 2010 | 18 | 0 |
| 2011 | 28 | 0 |
| 2012 | 29 | 0 |
| 2013 | 43 | 0 |
| 2014 | 40 | 0 |
| 2015 | 55 | 0 |
| 2016 | 59 | 1 |
| 2017 | 76 | 2 |
| 2018 | 66 | 1 |
| 2019 | 54 | 0 |
| 2020 | 80 | 2 |
| 2021 | 60 | 0 |
| 2022 | 60 | 0 |
| 2023 | 59 | 0 |
| 2024 | 64 | 0 |
| 2025 | 83 | 2 |
| 2026 | 59 | 0 |
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.
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? (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 | Decided |
|---|---|---|---|
| * | K934139 | Tomtec Echo-ViewSummary page 1…nd Image Analysis System Classification Name: Ultrasonic Pulsed Echo Imaging System Proprietary Name: Echo-View Easy-View Omni-View Predicate Device TomTec Echo-View K934139 Device Description The Echo-Viewis a software module for high performance computer systems based on Microsoft Windows NT™ 4.0 o… | 1995 |
What descends from it? (987)
See all 9871 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X & Surgical… | 2002 | 986 |
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 · 5 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 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 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 · 9 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 9 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 10 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 11 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?
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 | — |
What is it indicated for?
Echo-View™ 4.X is intended to retrieve, analyze and store digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.
Echo-View™ 4.x can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology.
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/K993398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993398: Echo View, Easy View, Omni View.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993398
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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