510(k) · Cleared
ClearedEchotech 3D Freescan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Echotech 3D Imaging Systems GmbH · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 6, 1998 as substantially equivalent to K963807 (Tomtec Imaging Systems, Inc., 1996) after a 99-day review. Its family tree reaches back 2 generations to 1995. 10 later devices descend from it.
- Decided
- May 6, 1998
- Review
- 99 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K941322 (1995). 10 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK941322 Echo-ScanTomographic Tech · 1995
- 1 generation backK963807 Tomtec Echo-ScanTomtec Imaging Systems, Inc. · 1996
- This deviceK980308 Echotech 3D FreescanEchotech 3D Imaging Systems GmbH · 1998
- Descendant · cites it directly · 4 of its ownK994385 Baby FaceSonora Medical Systems · 2000
- Descendant · cites it directly · 3 of its ownK013088 Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive…Echotech 3D Imaging Systems, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK012084 Sonoreal 3DBio Medi Com · 2001
- Descendant · cites it directly · 2 of its ownK020068 Sonoreal 3D SystemBio Medi Com · 2002
- Descendant · 2 generations on · 1 of its ownK030635 The Obsidian Pacs SystemObsidian Medical Technology, Inc. · 2003
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K994385Baby FaceSonora Medical Systems · 2000 · cites it directly4descendants
- K013088Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech Quanticon…Echotech 3D Imaging Systems, Inc. · 2002 · cites it directly3descendants
- K012084Sonoreal 3DBio Medi Com · 2001 · cites it directly3descendants
- K020068Sonoreal 3D SystemBio Medi Com · 2002 · cites it directly2descendants
- K030635The Obsidian Pacs SystemObsidian Medical Technology, Inc. · 2003 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941322 | Echo-Scan | Tomographic Tech | 1995 | — |
| −1 | K963807 | Tomtec Echo-Scan | Tomtec Imaging Systems, Inc. | 1996 | — |
| 0 (this device) | K980308 | Echotech 3D Freescan | Echotech 3D Imaging Systems GmbH | 1998 | — |
| +1 | K994385 | Baby Face | Sonora Medical Systems | 2000 | — |
| +1 | K013088 | Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech… | Echotech 3D Imaging Systems, Inc. | 2002 | — |
| +1 | K012084 | Sonoreal 3D | Bio Medi Com | 2001 | — |
| +1 | K020068 | Sonoreal 3D System | Bio Medi Com | 2002 | — |
| +2 | K030635 | The Obsidian Pacs System | Obsidian Medical Technology, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 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 |
|---|---|---|---|
| * | K963807 | Tomtec Echo-ScanSummary page 2…em Classification Name: Ultrasonic Pulsed Echo Imaging System Proprietary Name: EchoTech 3D FreeScan K9‘60‘30&3 pZor3 Predicate Device TomTec Echo-Scan K963807 dated December 18, 1996. Device Description The EchoTech 3D FreeScan is a high performance computer system based on Intel mothe… | 1996 |
What descends from it? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K994385 (Sonora Medical Systems, 2000) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K963807.
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 ECHOTECH 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and movement of ultrasound transducers for the systematic…
Read the full statement (100 words)
The ECHOTECH 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, 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/K980308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980308: Echotech 3D Freescan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980308
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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