510(k) · Cleared
ClearedSono-Scan, Sono-Scan Pro, Cardio Scan
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 May 9, 2002 as substantially equivalent to K993394 (Tomtec Imaging Systems GmbH, 1999) after a 78-day review. Its family tree reaches back 3 generations to 1995. 80 later devices descend from it.
- Decided
- May 9, 2002
- Review
- 78 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941322 (1995). 80 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK941322 Echo-ScanTomographic Tech · 1995
- 2 generations backK963807 Tomtec Echo-ScanTomtec Imaging Systems, Inc. · 1996
- 1 generation backK993394 Echo Scan, Easy ScanTomtec Imaging Systems GmbH · 1999
- This deviceK020561 Sono-Scan, Sono-Scan Pro, Cardio ScanTomtec Imaging Systems GmbH · 2002
- Descendant · cites it directly · 79 of its ownK110595 4D Sono-Scan 1.0Tomtec Imaging Systems GmbH · 2011
- Descendant · 2 generations on · 78 of its ownK132544 Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH · 2013
- Descendant · 3 generations on · 56 of its ownK150122 Tomtec-Arena TTA2Tomtec Imaging Systems GmbH · 2015 · Recalled
- Descendant · 4 generations on · 35 of its ownK170823 Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2017 · Recalled
- Descendant · 5 generations on · 20 of its ownK173341 Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 2017 · Recalled
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K1105954D Sono-Scan 1.0Tomtec Imaging Systems GmbH · 2011 · cites it directly79descendants
- K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH · 2013 · 2 generations on78descendants
- K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH · 2015 · 3 generations on56descendants
- K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2017 · 4 generations on35descendants
- K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 2017 · 5 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941322 | Echo-Scan | Tomographic Tech | 1995 | — |
| −2 | K963807 | Tomtec Echo-Scan | Tomtec Imaging Systems, Inc. | 1996 | — |
| −1 | K993394 | Echo Scan, Easy Scan | Tomtec Imaging Systems GmbH | 1999 | — |
| 0 (this device) | K020561 | Sono-Scan, Sono-Scan Pro, Cardio Scan | Tomtec Imaging Systems GmbH | 2002 | — |
| +1 | K110595 | 4D Sono-Scan 1.0 | Tomtec Imaging Systems GmbH | 2011 | — |
| +2 | K132544 | Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena | Tomtec Imaging Systems GmbH | 2013 | — |
| +3 | K150122 | Tomtec-Arena TTA2 | Tomtec Imaging Systems GmbH | 2015 | 1 |
| +4 | K170823 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2017 | 3 |
| +5 | K173341 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems | 2017 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 13 | 0 |
| 2021 | 5 | 0 |
| 2022 | 9 | 0 |
| 2023 | 9 | 0 |
| 2024 | 7 | 0 |
| 2025 | 17 | 0 |
| 2026 | 6 | 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.
Planning a device in IYO? 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 |
|---|---|---|---|
| * | K993394 | Echo Scan, Easy ScanSummary page 1…age Analysis System Classification Name: Ultrasonic Pulsed Echo Imaging System Proprietary Name: Sono-Scan Sono-Scan Pro Cardio-Scan Predicate Device TomTec Echo-Scan K993394 Device Description The TomTec acquisition software products Sono Scan and Cardio Scan are combining 3D and 4D Acquisition Softw… | 1999 |
What descends from it? (80)
See all 801 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110595 | 4D Sono-Scan 1.0 | 2011 | 79 |
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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K110595 (Tomtec Imaging Systems GmbH, 2011) has gone furthest, with 79 descendants of its own.
- 1 other device also cites its predicate K993394.
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?
Sono-Scan/Cardio-Scan™ is intended to acquire, store, retrieve and analyze digital ultrasound images and Color Doppler images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.
Sono-Scan/Cardio-Scan™ can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose image acquisition and digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastro-enterology, 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/K020561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020561: Sono-Scan, Sono-Scan Pro, Cardio Scan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020561
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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