510(k) · Cleared
ClearedTomtec Echo-Scan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomtec Imaging Systems, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Dec 18, 1996 as substantially equivalent to K941322 (Tomographic Tech, 1995) after an 86-day review. Its family tree reaches back 1 generation to 1995. 242 later devices descend from it.
- Decided
- Dec 18, 1996
- Review
- 86 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941322 (1995). 242 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK941322 Echo-ScanTomographic Tech · 1995
- This deviceK963807 Tomtec Echo-ScanTomtec Imaging Systems, Inc. · 1996
- Descendant · cites it directly · 212 of its ownK992886 Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C · 1999
- Descendant · 2 generations on · 211 of its ownK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
- Descendant · 2 generations on · 210 of its ownK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
- Descendant · 3 generations on · 209 of its ownK032281 Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003
- Descendant · 4 generations on · 205 of its ownK063130 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · Recalled
Showing 5 of 242 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 242 · See all- K992886Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C · 1999 · cites it directly212descendants
- K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001 · 2 generations on211descendants
- K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · 2 generations on210descendants
- K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003 · 3 generations on209descendants
- K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · 4 generations on205descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941322 | Echo-Scan | Tomographic Tech | 1995 | — |
| 0 (this device) | K963807 | Tomtec Echo-Scan | Tomtec Imaging Systems, Inc. | 1996 | — |
| +1 | K992886 | Powerview Ultrasound Workstation, Uidm-400A | Toshiba America Medical Systems, In.C | 1999 | — |
| +2 | K013633 | Ssa-770A, Aplio Ultrasound System | Toshiba America Medical Systems, In.C | 2001 | — |
| +2 | K022400 | Ssa-700A, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2002 | 1 |
| +3 | K032281 | Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2003 | — |
| +4 | K063130 | Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0 | Toshibamedical Systems Corporation | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 9 | 0 |
| 2013 | 5 | 0 |
| 2014 | 12 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 12 | 0 |
| 2018 | 19 | 0 |
| 2019 | 9 | 0 |
| 2020 | 20 | 0 |
| 2021 | 11 | 0 |
| 2022 | 16 | 0 |
| 2023 | 18 | 0 |
| 2024 | 13 | 0 |
| 2025 | 26 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | K941322 | Echo-ScanSummary page 1…igital Ultrasound Image Analysis System Classification Name: Ultrasonic Pulsed Echo Imaging System Proprietary Name: TomTec Echo-Scan Predicate Device TomTec Echo-Scan K941322, dated July 27, 1995 Device Description The TomTec Echo-Scan is a high performance computer system based on Intel motherboard a… | 1995 |
What descends from it? (242)
See all 2427 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992886 | Powerview Ultrasound Workstation, Uidm-400A | 1999 | 212 |
| K993394 | Echo Scan, Easy Scan | 1999 | 90 |
| K980308 | Echotech 3D Freescan | 1998 | 10 |
| K013088 | Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech Quanticon… | 2002 | 3 |
| K141870 | Breast Volume Navigator | 2014 | 2 |
| K140153 | Ventripoint Medical System | 2014 | 2 |
| K190314 | Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 | 2019 | 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?
- Its one ancestor has no recall.
- Of its descendants, K992886 (Toshiba America Medical Systems, In.C, 1999) has gone furthest, with 212 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 | — |
What is it indicated for?
The TomTec Echo-Scan is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. The Echo-Scan acquires sets of 2D images…
Read the full statement (161 words)
The TomTec Echo-Scan is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. The Echo-Scan acquires sets of 2D images and stores them digitally in the TomTec standard 3D image file format for subsequent 3D tomographic reconstruction and surface rendering with either the Echo-Scan or Echo-View. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology. The TomTec Freehand Scanning Device is intended for acquiring a sequence of conventional 2D ultrasound images with transducer position recorded for each image acquired. The resulting image data set is intended for storage in the TomTec standard 3D image file format for subsequent 3D tomographic image reconstruction.
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/K963807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963807: Tomtec Echo-Scan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963807
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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